CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3 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/NCT03183778
NCT03183778Phase 4Completed

Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.

NYU Langone Health·interventional·Posted Jun 12, 2017·Updated Dec 1, 2021

In Brief

A Phase 4 clinical trial evaluating Patiromer and Research Diet Menu for Chronic Kidney Diseases and Hyperkalemia. Completed, enrolled 3 participants across 1 site.

Detailed Summary

The purpose of this proof-of-concept controlled-feeding study is to determine whether patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a plant-rich diet.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 12, 2017
Enrollment StartMar 12, 2018
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.1 years ago

Interventions

Patiromerdrug

Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.

Research Diet Menudietary

During the study, participants will be asked to consume only the foods provided in the research diet