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

Completed · Phase 4

Conditions studied: Hyperkalemia, End Stage Renal Disease

In brief

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 facts

Study ID

NCT03781089

Run by

Duke University

People needed

36

Starts

2019-06-20

Expected to finish

2023-03-15

Last updated by the study team

2025-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females, age at least 18 years
• ESRD treated with thrice-weekly HD for ≥ 6 months.
• At least two measured pre-dialysis serum [K] ≥ 5.5 mEq/L or one [K] ≥ 6.0 mEq/L noted over the past three months
• Current use of dialysate with potassium concentration ≤ 2 mEq/L
• Typical consumption of at least two meals per day
• Have received customary dietary instruction over prior month
• Considered by the treating physician(s) to be in otherwise stable clinical condition.
• If patient is of childbearing potential, he/she will be willing to avoid pregnancy during the study using an acceptable birth control method.

You may not qualify if…

• Not considered by the treating physician(s) to be adherent with recommended dialysis schedule and prescribed medications
• Life expectancy < 3 months
• Dialysis-dependent for less than 6 months
• Non-elective hospitalization in prior 3 months
• Currently prescription of oral potassium supplements
• In the prior 3 months, therapy with oral potassium-lowering medication
• Underlying severe gastrointestinal disorders, including history of ischemic bowel.
• Corrected serum calcium concentration > 10.5 mg/dL in prior three months
• Anticipated kidney transplant within the next 3 months
• Prisoners or others who are involuntarily incarcerated or detained
• Pregnant, breastfeeding, or considering pregnancy.
• Participation in a clinical trial of an experimental treatment within the past 30 days

Where it is running

• DaVita Dialysis Sites — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.