CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 295 enrolled
Drug / intervention
Patiromer +2 moredrug
Likely dose
Spironolactone 25 mgfrom 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/NCT03071263
NCT03071263Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease

Relypsa, Inc.·interventional·Posted Mar 6, 2017·Updated May 12, 2021

In Brief

A Phase 2 clinical trial evaluating Patiromer, Placebo, and 1 other intervention for Hyperkalemia and Resistant Hypertension. Completed, enrolled 295 participants across 40 sites in 9 countries.

Detailed Summary

The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia, Resistant Hypertension
CountriesBulgaria, Croatia, Georgia, Germany, Hungary, South Africa, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 6, 2017
Enrollment StartJan 23, 2017
Primary CompletionNov 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.3 years ago

Interventions

Patiromerdrug

2 packets/day starting dose, administered orally

Placebodrug

2 packets/day starting dose, administered orally

Spironolactonedrug

25 mg tablet/day starting dose, administered orally