Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia

Study identifier:D9482C00001

ClinicalTrials.gov identifier:NCT03172702

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS (Sodium Zirconium Cyclosilicate) in Japanese Subjects With Hyperkalemia

Medical condition

Hyperkalemia

Phase

Phase 3

Healthy volunteers

Study drug

Zirconium Cyclosilicate

Sex

All

Actual Enrollment

150

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 04 Sept 2017

Primary Completion Date: 06 Jul 2019

Study Completion Date: 06 Jul 2019

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Verification:

Verified 01 Apr 2020 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

-Provision of informed consent prior to any study specific procedures.
-Patients aged ≥18. For patients aged <20 years, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
-Two consecutive i-STAT potassium values, measured 60-minutes (± 15 minutes) apart, both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Correction Phase Study Day 1.
-Patients who are on peritoneal dialysis (PD) can be enrolled if their SK level is ≥5.5 and ≤ 6.5 mmol/L in two consecutive i-STAT potassium evaluation at least 24 hours apart before Day 1 (in each evaluation, two i-STAT potassium measurements at least 1 hour apart are required). i-STAT potassium measurement should be performed in the morning before breakfast and in the evening before dinner in PD patients on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD), respectively.
-Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test within 1 day prior to the first dose of ZS on Correction Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 1 year are not considered to be of childbearing potential.

Exclusion Criteria

-Patients treated with lactulose, rifaxan (rifaximin), or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS.
-Patients treated with resins (such as sevelamer hydrochloride, sodium polystyrene sulfonate [SPS; e.g. Kayexalate®] or calcium polystyrene sulfonate [CPS]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug. Washout of SPS and CPS for 7 days (or longer) prior to the first dose of ZS is allowed, if termination of CPS or SPS is judged to be clinically acceptable by the investigator. Documented informed consent has to be obtained prior to the washout.
-Patients with a life expectancy of less than 12 months
-Female patients who are pregnant, lactating, or planning to become pregnant
-Patients who have an active or history of diabetic ketoacidosis
-Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
-Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
-Patients with cardiac arrhythmias that require immediate treatment
-Hemodialysis patients (including those who are on both PD and hemodialysis [HD])
-Patients who have been on PD less than 6 months or more than 6 months with a history of hypokalemia within 6 months before Correction Phase Day 1
-Documented Glomerular Filtration Rate (GFR) < 15 mL/min within 90 days prior to study entry (Non peritoneal dialysis (PD) patients only)
-If patients joined ZS study in the past, the patients cannot join this study within the last 30 days of the last study drug administration day.

Location

Research Site

Chiba-shi, Japan, 260-8712

Location

Research Site

Hanyu-shi, Japan, 348-8505

Location

Research Site

Koga-shi, Japan, 306-0041

Location

Research Site

Shizuoka-shi, Japan, 421-0117

Location

Research Site

Yao-shi, Japan, 581-0011

Location

Research Site

Shimajiri-gun, Japan, 901-0493

Location

Research Site

Higashiibaraki-gun, Japan, 311-3193

Location

Research Site

Kawachinagano-shi, Japan, 586-8521

Arms	Assigned Interventions
Experimental: Sodium Zirconium Cyclosilicate Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.	-

Arms

Assigned Interventions

Experimental: Sodium Zirconium Cyclosilicate
Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Japanese patients with hyperkalemia were recruited to this open-label, single-arm study with a flexible dosing regimen conducted in 44 study centers in Japan. First patient enrolled in September 2017; last patient completed in July 2019.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For inclusion, patients were required to have 2 consecutive iSTAT (portable blood analyzer) potassium values, measured 60 minutes apart, both ≥5.1 millimole per liter (mmol/L) and measured within 1 day before the first dose of sodium zirconium cyclosilicate (ZS) on Correction Phase (CP) Day 1.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 grams (g) ZS three times daily (TID) for a maximum of 72 hours. If a patient became normokalemic (iSTAT potassium ≥3.5 and ≤5.0 mmol/L) after 24, 48 or 72 hours they progressed to the Maintenance Phase (MP). MP (up to 12 months): Patients received a starting dose of 5 g ZS once daily (QD) and based on the iSTAT potassium measurements the ZS dose could be increased to 10 g or 15 g QD or decreased to 5 g once every other day (QOD) or 2.5 g QD.

Description

Sodium zirconium cyclosilicate

CP (up to 3 days):
Patients received 10 grams (g) ZS three times daily (TID) for a maximum of 72 hours. If a patient became normokalemic (iSTAT potassium ≥3.5 and ≤5.0 mmol/L) after 24, 48 or 72 hours they progressed to the Maintenance Phase (MP).

MP (up to 12 months):
Patients received a starting dose of 5 g ZS once daily (QD) and based on the iSTAT potassium measurements the ZS dose could be increased to 10 g or 15 g QD or decreased to 5 g once every other day (QOD) or 2.5 g QD.

Participant Flow: Overall Study

	Sodium zirconium cyclosilicate
STARTED	150
Received treatment in CP	150
Received treatment in MP	150
COMPLETED	122
NOT COMPLETED	28
Adverse Event	9
Death	2
Study-specific Withdrawal Criteria	10
Withdrawal by Subject	5
Not Specified	2

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Baseline Measures

	Sodium zirconium cyclosilicate
Number of Participants [units: Participants]	150
Age Continuous [units: years] Mean ± Standard Deviation	71.5 ± 10.8
Sex: Female, Male [units: Participants]
Female	38
Male	112
Race/Ethnicity, Customized [units: Participants] Asian	150

Outcome Measures

1. Primary Outcome Measure: Number of Patients who Experienced Adverse Events (AEs) in the MP [ Time Frame: First MP dose up to 1 day (2 days for QOD regimen) after last MP dose. ]

Measure Type	Primary
Measure Name	Number of Patients who Experienced Adverse Events (AEs) in the MP
Measure Description	The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
Time Frame	First MP dose up to 1 day (2 days for QOD regimen) after last MP dose.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis set for the MP (SAF-MP) included all patients treated with at least 1 dose of MP ZS and who had any MP safety data.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Number of Patients who Experienced Adverse Events (AEs) in the MP [units: Participants]
Any AE	131
Any AE with outcome death	2
Any SAE	27
Any severe AE	9
Any AE leading to ZS discontinuation	12
Any causally related AE	30
Oedema-related AE	31
Cardiac failure	10
Hypertension	24

No statistical analysis provided for Number of Patients who Experienced Adverse Events (AEs) in the MP

2. Secondary Outcome Measure: Percentage of Patients who were Normokalemic in the MP [ Time Frame: MP Day 1 to End of Study visit (up to 12 months). ]

Measure Type	Secondary
Measure Name	Percentage of Patients who were Normokalemic in the MP
Measure Description	The percentage of patients who were normokalemic at each study visit in the MP is presented. Normokalemia was defined as a serum potassium (S-K) level of ≥ 3.5 and ≤ 5.0 mmol/L. The percentage of patients who were normokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Time Frame	MP Day 1 to End of Study visit (up to 12 months).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis set for the MP (FAS-MP) included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Percentage of Patients who were Normokalemic in the MP [units: Percentage of patients] Number (95% Confidence Interval)
MP Day 1	82.0 (74.9 to 87.8)
MP Day 2	78.7 (71.2 to 84.9)
MP Day 5	79.9 (72.5 to 86.0)
MP Day 12	67.8 (59.6 to 75.2)
MP Day 19	65.5 (57.3 to 73.2)
MP Day 26	72.3 (64.3 to 79.3)
MP Day 54	76.4 (68.6 to 83.1)
MP Day 82	72.1 (63.9 to 79.4)
MP Day 110	75.9 (67.9 to 82.8)
MP Day 138	85.1 (77.9 to 90.6)
MP Day 166	78.0 (70.0 to 84.8)
MP Day 194	75.4 (67.1 to 82.5)
MP Day 222	70.5 (61.9 to 78.2)
MP Day 250	79.8 (71.9 to 86.4)
MP Day 278	75.6 (67.2 to 82.8)
MP Day 306	74.2 (65.6 to 81.6)
MP Day 334	83.1 (75.3 to 89.2)
MP Day 362	79.5 (71.3 to 86.3)
Last on-treatment Visit	78.0 (70.5 to 84.3)
End of Study Visit	38.4 (30.4 to 46.8)

No statistical analysis provided for Percentage of Patients who were Normokalemic in the MP

3. Secondary Outcome Measure: Percentage of Patients with Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP [ Time Frame: MP Day 2 to Day 362. ]

Measure Type	Secondary
Measure Name	Percentage of Patients with Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP
Measure Description	The percentage of patients who had an average S-K level of ≤5.1 mmol/L and ≤5.5 mmol/L over the MP up to Day 362 is presented.
Time Frame	MP Day 2 to Day 362.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Percentage of Patients with Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP [units: Percentage of patients] Number (95% Confidence Interval)
≤5.1 mmol/L	93.3 (88.1 to 96.8)
≤5.5 mmol/L	100.0 (97.6 to 100.0)

No statistical analysis provided for Percentage of Patients with Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP

4. Secondary Outcome Measure: Percentage of Patients who were Hypokalemic in the MP [ Time Frame: MP Day 1 to End of Study visit (up to 12 months). ]

Measure Type	Secondary
Measure Name	Percentage of Patients who were Hypokalemic in the MP
Measure Description	The percentage of patients who were hypokalemic at each study visit in the MP is presented. Hypokalemia was defined as a S-K level of < 3.5 mmol/L. The percentage of patients who were hypokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Time Frame	MP Day 1 to End of Study visit (up to 12 months).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Percentage of Patients who were Hypokalemic in the MP [units: Percentage of patients]
MP Day 1	0.0
MP Day 2	0.0
MP Day 5	0.0
Day 12	0.0
MP Day 19	0.0
MP Day 26	0.7
MP Day 54	2.8
MP Day 82	3.6
MP Day 110	0.7
MP Day 138	2.2
MP Day 166	1.5
MP Day 194	0.8
MP Day 222	1.6
MP Day 250	2.3
MP Day 278	1.6
MP Day 306	1.6
MP Day 334	1.6
MP Day 362	1.6
Last on-treatment Visit	5.3
End of Study Visit	0.7

No statistical analysis provided for Percentage of Patients who were Hypokalemic in the MP

5. Secondary Outcome Measure: Percentage of Patients who were Hyperkalemic in the MP [ Time Frame: MP Day 1 to End of Study visit (up to 12 months). ]

Measure Type	Secondary
Measure Name	Percentage of Patients who were Hyperkalemic in the MP
Measure Description	The percentage of patients who were hyperkalemic at each study visit in the MP is presented. Hyperkalemia was defined as a S-K level of >5.0 mmol/L. The percentage of patients who were hyperkalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Time Frame	MP Day 1 to End of Study visit (up to 12 months).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Percentage of Patients who were Hyperkalemic in the MP [units: Percentage of patients]
MP Day 1	18.0
MP Day 2	21.3
MP Day 5	20.1
MP Day 12	32.2
MP Day 19	34.5
MP Day 26	27.0
MP Day 54	20.8
MP Day 82	24.3
MP Day 110	23.4
MP Day 138	12.7
MP Day 166	20.5
MP Day 194	23.8
MP Day 222	27.9
MP Day 250	17.8
MP Day 278	22.8
MP Day 306	24.2
MP Day 334	15.3
MP Day 362	18.9
Last on-treatment Visit	16.7
End of Study Visit	61.0

No statistical analysis provided for Percentage of Patients who were Hyperkalemic in the MP

6. Secondary Outcome Measure: Mean Change from CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP [ Time Frame: CP Day 1 to MP Day 362. ]

Measure Type	Secondary
Measure Name	Mean Change from CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
Measure Description	The mean changes from the CP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.
Time Frame	CP Day 1 to MP Day 362.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Mean Change from CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP [units: mmol/L] Mean (Standard Deviation)
MP Day 1	-0.93 (0.44)
Entire MP (Day 2 to Day 362)	-0.98 (0.42)
MP Day 82 to Day 362	-1.07 (0.52)
MP Day 2 to Day 82	-0.91 (0.41)
MP Day 110 to Day 166	-1.11 (0.61)
MP Day 194 to Day 278	-1.01 (0.51)
MP Day 306 to Day 362	-1.06 (0.55)

No statistical analysis provided for Mean Change from CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP

7. Secondary Outcome Measure: Mean Change from MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP [ Time Frame: MP Day 1 to Day 362. ]

Measure Type	Secondary
Measure Name	Mean Change from MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
Measure Description	The mean changes from the MP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the MP was defined as the measurement taken in the morning of the day of entering the MP (MP Day 1).
Time Frame	MP Day 1 to Day 362.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Mean Change from MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP [units: mmol/L] Mean (Standard Deviation)
Entire MP (Day 2 to Day 362)	-0.07 (0.33)
MP Day 82 to Day 362	-0.14 (0.42)
MP Day 2 to Day 82	-0.01 (0.36)
MP Day 110 to Day 166	-0.16 (0.50)
MP Day 194 to Day 278	-0.07 (0.42)
MP Day 306 to Day 362	-0.11 (0.47)

No statistical analysis provided for Mean Change from MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP

8. Secondary Outcome Measure: Mean Number of Normokalemic Days During the MP [ Time Frame: MP Day 1 to Day 362. ]

Measure Type	Secondary
Measure Name	Mean Number of Normokalemic Days During the MP
Measure Description	The number of normokalemic days during the MP was calculated assuming the time interval between assessments was normokalemic if both the beginning and end assessments for that time interval displayed normal S-K values. If an intermediate scheduled assessment time point was missing, then the scheduled assessment was regarded as not normokalemic. The mean number of normokalemic days for a patient in the MP is presented.
Time Frame	MP Day 1 to Day 362.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Mean Number of Normokalemic Days During the MP [units: Days] Mean (Standard Deviation)	207.7 (109.5)

No statistical analysis provided for Mean Number of Normokalemic Days During the MP

9. Secondary Outcome Measure: Mean Change in S-K Level from Last On-treatment MP Visit to the End of Study [ Time Frame: MP Day 1 to End of Study visit (up to 12 months). ]

Measure Type	Secondary
Measure Name	Mean Change in S-K Level from Last On-treatment MP Visit to the End of Study
Measure Description	The mean change in the S-K level from the last on-treatment MP visit to the End of Study is presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Time Frame	MP Day 1 to End of Study visit (up to 12 months).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Mean Change in S-K Level from Last On-treatment MP Visit to the End of Study [units: mmol/L] Mean (Standard Deviation)	0.66 (0.53)

No statistical analysis provided for Mean Change in S-K Level from Last On-treatment MP Visit to the End of Study

10. Secondary Outcome Measure: Change from CP Baseline in S-Aldosterone Levels Over the MP [ Time Frame: CP Day 1, MP Day 166 and MP Day 362. ]

Measure Type	Secondary
Measure Name	Change from CP Baseline in S-Aldosterone Levels Over the MP
Measure Description	The mean change from CP baseline to MP Day 166 and MP Day 362 in S-aldosterone levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.
Time Frame	CP Day 1, MP Day 166 and MP Day 362.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Change from CP Baseline in S-Aldosterone Levels Over the MP [units: Picomole per liter (pmol/L)] Mean (Standard Deviation)
MP Day 166	-56.355 (124.050)
MP Day 362	-48.561 (129.261)
Last on-treatment Visit	-48.808 (125.081)

No statistical analysis provided for Change from CP Baseline in S-Aldosterone Levels Over the MP

11. Secondary Outcome Measure: Percentage of Patients with Normal S-Aldosterone Levels Over the MP [ Time Frame: CP Day 1, MP Day 166 and MP Day 362. ]

Measure Type	Secondary
Measure Name	Percentage of Patients with Normal S-Aldosterone Levels Over the MP
Measure Description	The percentage of patients with normal S-aldosterone levels up to Day 362 of the MP is presented. The normal range for S-aldosterone was 0 - 776.72 pmol/L. In addition, the percentage of patients with normal S-aldosterone levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.
Time Frame	CP Day 1, MP Day 166 and MP Day 362.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Percentage of Patients with Normal S-Aldosterone Levels Over the MP [units: Percentage of patients] Number (95% Confidence Interval)
CP Baseline	99.3 (96.3 to 100.0)
MP Day 166	100.0 (97.2 to 100.0)
MP Day 362	100.0 (97.0 to 100.0)
Last on-treatment Visit	100.0 (97.2 to 100.0)

No statistical analysis provided for Percentage of Patients with Normal S-Aldosterone Levels Over the MP

12. Secondary Outcome Measure: Change from CP Baseline in S-Bicarbonate Levels Over the MP [ Time Frame: CP Day 1, and MP Day 1 to End of Study visit (up to 12 months). ]

Measure Type	Secondary
Measure Name	Change from CP Baseline in S-Bicarbonate Levels Over the MP
Measure Description	The mean change from CP baseline to timepoints in the MP in S-bicarbonate levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Time Frame	CP Day 1, and MP Day 1 to End of Study visit (up to 12 months).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Change from CP Baseline in S-Bicarbonate Levels Over the MP [units: mmol/L] Mean (Standard Deviation)
MP Day 1	1.20 (1.64)
MP Day 5	1.20 (1.71)
MP Day 12	1.46 (1.91)
MP Day 19	1.29 (2.27)
MP Day 26	1.64 (2.22)
MP Day 82	1.45 (2.90)
MP Day 166	1.55 (2.53)
MP Day 250	1.84 (2.64)
MP Day 334	1.73 (2.75)
MP Day 362	1.50 (2.85)
Last on-treatment Visit	1.70 (2.87)
End of Study Visit	0.55 (2.49)

No statistical analysis provided for Change from CP Baseline in S-Bicarbonate Levels Over the MP

13. Secondary Outcome Measure: Percentage of Patients with Normal S-Bicarbonate Levels Over the MP [ Time Frame: CP Day 1 and MP Day 1 to End of Study visit (up to 12 months). ]

Measure Type	Secondary
Measure Name	Percentage of Patients with Normal S-Bicarbonate Levels Over the MP
Measure Description	The percentage of patients with normal S-bicarbonate levels up to the End of Study visit in the MP is presented. The normal range for S-bicarbonate was 17 - 32 mmol/L. In addition, the percentage of patients with normal S-bicarbonate levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Time Frame	CP Day 1 and MP Day 1 to End of Study visit (up to 12 months).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Percentage of Patients with Normal S-Bicarbonate Levels Over the MP [units: Percentage of patients] Number (95% Confidence Interval)
CP Baseline	90.0 (84.0 to 94.3)
MP Day 1	98.0 (94.2 to 99.6)
MP Day 5	98.6 (95.2 to 99.8)
MP Day 12	98.0 (94.2 to 99.6)
MP Day 19	97.3 (93.2 to 99.3)
MP Day 26	98.6 (95.2 to 99.8)
MP Day 82	97.8 (93.8 to 99.6)
MP Day 166	99.2 (95.9 to 100.0)
MP Day 250	99.2 (95.8 to 100.0)
MP Day 334	97.6 (93.1 to 99.5)
MP Day 362	95.9 (90.7 to 98.7)
Last on-treatment Visit	96.7 (92.4 to 98.9)
End of Study Visit	93.8 (88.6 to 97.1)

No statistical analysis provided for Percentage of Patients with Normal S-Bicarbonate Levels Over the MP

14. Secondary Outcome Measure: Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores [ Time Frame: CP Day 1 (baseline) and MP Day 362 (post-baseline). ]

Measure Type	Secondary
Measure Name	Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Measure Description	Patients completed the SF-36 v2 questionnaire on Day 1 of the CP and on Day 362 of the MP. The responses to the items assessing the physical and mental health of the patients determined the PCS and MCS based on a standard algorithm. The PCS and MCS scores ranged from 0 (worst possible health state) to 100 (best possible health state). The mean PCS and MCS are presented for the baseline and post-baseline assessments.
Time Frame	CP Day 1 (baseline) and MP Day 362 (post-baseline).
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores [units: Scale score] Mean (Standard Deviation)
Baseline: PCS	49.106 (6.292)
Post-baseline: PCS	49.348 (6.659)
Baseline: MCS	51.126 (8.375)
Post-baseline: MCS	50.350 (8.384)

No statistical analysis provided for Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

15. Secondary Outcome Measure: Mean Change from CP Baseline in the Mean S-K Levels in the CP [ Time Frame: CP Day 1 to Day 3. ]

Measure Type	Secondary
Measure Name	Mean Change from CP Baseline in the Mean S-K Levels in the CP
Measure Description	The mean change from the CP baseline at 24, 48 and 72 hours in the CP is presented. The mean change from baseline to the last on-treatment CP value is also presented. The last on-treatment value was defined as the last measurement taken with 1 day (2 days if on the QOD regimen) after the last ZS dose. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.
Time Frame	CP Day 1 to Day 3.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The CP full analysis set (FAS-CP) included all patients who received at least 1 dose of ZS during the CP and who had any post-baseline CP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Mean Change from CP Baseline in the Mean S-K Levels in the CP [units: mmol/L] Mean (Standard Deviation)
24 hours	-0.78 (0.39)
48 hours	-1.30 (0.39)
72 hours	NA (NA)^[1]
Last on-treatment Visit	-0.93 (0.44)

No statistical analysis provided for Mean Change from CP Baseline in the Mean S-K Levels in the CP

16. Secondary Outcome Measure: Percentage of Patients who were Normokalemic in the CP [ Time Frame: CP Day 1 to Day 3. ]

Measure Type	Secondary
Measure Name	Percentage of Patients who were Normokalemic in the CP
Measure Description	The percentage of patients who were normokalemic at 24, 48 and 72 hours in the CP is presented. Normokalemia was defined as a S-K level of ≥ 3.5 and ≤ 5.0 mmol/L.
Time Frame	CP Day 1 to Day 3.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS-CP included all patients who received at least 1 dose of ZS during the CP and who had any post-baseline CP S-K values.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Percentage of Patients who were Normokalemic in the CP [units: Percentage of patients] Number (95% Confidence Interval)
24 hours	65.3 (57.1 to 72.9)
48 hours	81.3 (74.2 to 87.2)
72 hours	82.0 (74.9 to 87.8)

No statistical analysis provided for Percentage of Patients who were Normokalemic in the CP

17. Secondary Outcome Measure: Number of Patients who Experienced AEs in the CP [ Time Frame: Day 1 of CP to last CP dose + 1 day or first MP dose -1 day, earlier. ]

Measure Type	Secondary
Measure Name	Number of Patients who Experienced AEs in the CP
Measure Description	The number of patients who experienced any AE, including SAEs, those which had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the CP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
Time Frame	Day 1 of CP to last CP dose + 1 day or first MP dose -1 day, earlier.
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The SAF-CP included all patients treated with at least 1 dose of CP ZS and who had any CP safety data.

Reporting Groups

	Description
Sodium zirconium cyclosilicate	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours. MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Measured Values

	Sodium zirconium cyclosilicate
Number of Participants Analyzed [units:participants]	150
Number of Patients who Experienced AEs in the CP [units: Participants]
Any AE	5
Any AE with outcome death	0
Any SAE	1
Any severe AE	0
Any AE leading to ZS discontinuation	0
Any causally related AE	0
Oedema-related AE	0
Cardiac failure	0
Hypertension	0

No statistical analysis provided for Number of Patients who Experienced AEs in the CP

Serious Adverse Events

Time Frame	For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
Additional Description	AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.

Reporting Groups

	Description
Correction Phase	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours.
Maintenance Phase	MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Serious Adverse Events

Correction Phase

Maintenance Phase

Total, serious adverse events

# participants affected / at risk

1/150 (0.67%)

27/150 (18.00%)

Metabolism and nutrition disorders

Diabetes mellitus¹,^†

# participants affected / at risk

1/150 (0.67%)

0/150 (0.00%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/150 (0.00%)

3/150 (2.00%)

Infections and infestations

Pyelonephritis¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lymphoma¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Undifferentiated sarcoma¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Nervous system disorders

Carotid artery stenosis¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Nervous system disorders

Cubital tunnel syndrome¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Nervous system disorders

Lacunar infarction¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Nervous system disorders

Transient ischaemic attack¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Eye disorders

Cataract¹,^†

# participants affected / at risk

0/150 (0.00%)

2/150 (1.33%)

Eye disorders

Diabetic retinopathy¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Eye disorders

Eyelid ptosis¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Eye disorders

Strabismus¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Cardiac disorders

Angina unstable¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Cardiac disorders

Cardiac failure¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Cardiac disorders

Cardiac failure acute¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Cardiac disorders

Cardiac failure congestive¹,^†

# participants affected / at risk

0/150 (0.00%)

4/150 (2.67%)

Cardiac disorders

Ventricular fibrillation¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Vascular disorders

Peripheral artery stenosis¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Hepatobiliary disorders

Bile duct stone¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

General disorders

Oedema peripheral¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

Injury, poisoning and procedural complications

Post procedural fistula¹,^†

# participants affected / at risk

0/150 (0.00%)

1/150 (0.67%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA v22.0

Other Adverse Events

Time Frame	For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.
Additional Description	AE data is presented for the SAF-MP which included all patients treated with at least 1 dose of MP ZS and had any MP safety data, and for the SAF-CP which included all patients treated with at least 1 dose of CP ZS and had any CP safety data.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Correction Phase	CP (up to 3 days): Patients received 10 g ZS TID for a maximum of 72 hours.
Maintenance Phase	MP (up to 12 months): Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.

Other Adverse Events

Correction Phase

Maintenance Phase

Total, other (not including serious) adverse events

# participants affected / at risk

1/150 (0.67%)

79/150 (52.67%)

General disorders

Oedema peripheral¹,^†

# participants affected / at risk

0/150 (0.00%)

23/150 (15.33%)

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

1/150 (0.67%)

36/150 (24.00%)

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

0/150 (0.00%)

23/150 (15.33%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

0/150 (0.00%)

20/150 (13.33%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA v22.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca
Phone	+18772409479
E-mail:	[email protected]

Documents available

D9482C0000 redacted CSP
Download
D9482C00001 redacted SAP
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

D9482C0000 redacted CSP

D9482C00001 redacted SAP

Trial Results Summaries