CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,195 enrolled
Drug / intervention
Patiromer +1 moredrug
Likely dose
Patiromer 1 packet daily, titrated by 1 packet per day in intervals of at least 1 week (±3 days) based on treatment algorithmAI-extracted
Key inclusion· 6
  • ✓Age ≥18 years
  • ✓Symptomatic reduced ejection fraction heart failure
  • ✓Currently receiving beta-blocker for heart failure (unless unable to tolerate)
  • ✓Kidney function not more than mild or moderately impaired
Key exclusion· 3
  • ✕Acute decompensated heart failure within 4 weeks before screening
  • ✕Significant primary aortic or mitral valvular disease (secondary mitral regurgitation allowed)
  • ✕Heart transplantation or planned heart transplantation (on transplant waiting list)

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

Search/NCT03888066
NCT03888066Phase 3Completed
CompareCT.gov

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)

Vifor Pharma, Inc.·interventional·Posted Mar 25, 2019·Updated Feb 24, 2023

In Brief

A Phase 3 clinical trial evaluating Patiromer and Placebos for Hyperkalemia. Completed, enrolled 1,195 participants across 415 sites in 21 countries.

Detailed Summary

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Russia, Serbia, Spain, Ukraine, United Kingdom, United States
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartApr 24, 2019
Primary CompletionSep 2, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.3 years ago

Interventions

Patiromerdrug

The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Placebosdrug

The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).