A study to test whether ZS (Sodium Zirconium Cyclosilicate) can reduce the incidence of increased blood potassium levels among dialized patients. - DIALIZE

Study identifier:D9480C00006

ClinicalTrials.gov identifier:NCT03303521

EudraCT identifier:2017-003029-14

CTIS identifier:N/A

Study Complete

Official Title

A phase 3b, multicenter, prospective, randomized, double blind, placebocontrolled study to reduce incidence of pre-dialysis hyperkalemia with Sodium Zirconium Cyclosilicate (DIALIZE)

Medical condition

Hyperkalemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Placebo, Sodium Zirconium Cyclosilicate (ZS)

Sex

All

Actual Enrollment

196

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 14 Dec 2017
Primary Completion Date: 07 Nov 2018
Study Completion Date: 07 Nov 2018

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria