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.

No locations available

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.

Documents available

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

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]