Status:
COMPLETED
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
Lead Sponsor:
Duke University
Collaborating Sponsors:
Vifor Pharma
Conditions:
Hyperkalemia
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 con...
Detailed Description
This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03781089
Start Date
June 20 2019
End Date
March 15 2023
Last Update
May 30 2025
Active Locations (1)
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1
DaVita Dialysis Sites
Durham, North Carolina, United States, 27713