CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Patiromerdrug
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/NCT03326583
NCT03326583Phase 2Completed
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The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia

Dominic Raj·interventional·Posted Oct 31, 2017·Updated May 9, 2023

In Brief

A Phase 2 clinical trial evaluating Patiromer for ESRD and 2 related conditions. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsESRD, Hyperkalemia, End Stage Renal Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 31, 2017
Enrollment StartNov 1, 2017
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.7 years ago

Interventions

Patiromerdrug

Patiromer will be orally self-administered by participants.