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Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

NCT02163499 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 751

Last updated 2018-06-27

Study results available
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Summary

The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.

Conditions

  • Hyperkalemia

Interventions

DRUG

Sodium Zirconium Cyclosilicate

Acute Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) for 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) based on i-STAT potassium measurements up to 12 months.

Sponsors & Collaborators

  • ZS Pharma, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States
  • Australia
  • Germany
  • Netherlands
  • Romania
  • South Africa
  • United Kingdom

Study Locations

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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 NCT02163499 on ClinicalTrials.gov