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Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.

NCT02088073 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2018-12-07

Study results available
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Summary

It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was established during the open-label acute phase versus no difference between each ZS dose (highest to lowest) versus placebo control (null hypothesis).

Conditions

  • Hyperkalemia

Interventions

DRUG

Sodium zirconium cyclosilicate

Sodium zirconium cyclosilicate

DRUG

Placebo

Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days (maintenance phase)

Sponsors & Collaborators

  • ZS Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Henrik Rasmussen, MD, PhD · ZS Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-08-31
Completion
2015-01-31

Countries

  • United States
  • Australia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

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 NCT02088073 on ClinicalTrials.gov