MedTrace Logo

A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

NCT01810939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2021-06-03

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.

Conditions

  • Chronic Kidney Disease (CKD)
  • Hyperkalemia (HK)

Interventions

DRUG

Patiromer

DRUG

Placebo

Sponsors & Collaborators

  • Relypsa, Inc.

    lead INDUSTRY

Principal Investigators

  • Director Clinical Operations · Relypsa, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-07-31
Completion
2013-08-31

Countries

  • United States
  • Croatia
  • Czechia
  • Denmark
  • Georgia
  • Hungary
  • Italy
  • Serbia
  • Slovenia
  • Ukraine

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 NCT01810939 on ClinicalTrials.gov