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A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.

NCT03528681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-05-14

Study results available
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Summary

To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following 24 or 48 hours of initial ZS therapy (10g TID).

Conditions

  • Hyperkalemia

Interventions

DRUG

Sodium Zirconium Cyclosilicate 5g

Suspension administered Sodium Zirconium Cyclosilicate 5g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.

DRUG

Sodium Zirconium Cyclosilicate 10g

Suspension administered Sodium Zirconium Cyclosilicate 10g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.

DRUG

Placebo

Suspension administered orally placebo once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2022-09-15
Completion
2022-09-15

Countries

  • China
  • India

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03528681 on ClinicalTrials.gov