Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 20, 2019

Primary Completion Date

March 15, 2023

Study Completion Date

March 15, 2023

Conditions
HyperkalemiaEnd Stage Renal Disease
Interventions
DRUG

Patiromer Oral Powder Product

Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol

Trial Locations (1)

27713

DaVita Dialysis Sites, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Vifor Pharma

INDUSTRY

lead

Duke University

OTHER

NCT03781089 - Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients | Biotech Hunter | Biotech Hunter