CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
patiromer +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01130597
NCT01130597Phase 2Completed

A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for Patiromer in Heart Failure Patients With Chronic Kidney Disease

Relypsa, Inc.·interventional·Posted May 26, 2010·Updated May 12, 2021

In Brief

A Phase 2 clinical trial evaluating patiromer and spironolactone for Heart Failure. Completed, enrolled 63 participants across 13 sites in 2 countries.

Detailed Summary

The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesGeorgia, Slovenia
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 26, 2010
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.1 years ago

Interventions

patiromerdrug

Active investigational drug

spironolactonedrug