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

NCT03781089 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-30

Study results available
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Summary

The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • John P Middleton, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2023-03-15
Completion
2023-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781089 on ClinicalTrials.gov