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

No

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

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria