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

NCT02875834 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2020-08-19

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 two days of initial ZS therapy (10g TID).

Conditions

  • Hyperkalemia

Interventions

DRUG

Sodium Zirconium Cyclosilicate (ZS) 10g

Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)

DRUG

Sodium Zirconium Cyclosilicate (ZS) 5g

Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.

DRUG

Sodium Zirconium Cyclosilicate (ZS) 10g

Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.

DRUG

Placebo

Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.

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
2017-03-03
Primary Completion
2018-02-14
Completion
2018-02-14

Countries

  • Japan
  • Russia
  • South Korea
  • Taiwan

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 NCT02875834 on ClinicalTrials.gov