Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated With Hemodialysis (PEARL-HD)

Pro00088688

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.

2019-06-20

2023-03-15

2023-03-15

Completed

Early phase I

36

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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 our clinical practice group. A total of 40 patients (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The study is open-label and therefore the subjects, coordinators and investigators are not blinded to the intervention. Titration of the patiromer will require viewing of the serum potassium values. During the data analysis, however, personnel involved will remain blinded.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

2023-06-29