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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT03781089
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patiromer Oral Powder Product — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 20, 2019
Status verified
May 2025
Primary completion
Mar 15, 2023
Completion
Mar 15, 2023

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: Usual care arm
    Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol

Primary Outcome Measure

Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L [ Time Frame: Week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
DaVita Dialysis SitesDurhamNorth Carolina27713-

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By research site
DaVita Dialysis Sites· Durham, NC

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