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Clinical Trial Details

Trial ID: L1052
Source ID: NCT03781089
Associated Drug: Patiromer Oral Powder Product
Title: Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hyperkalemia|End Stage Renal Disease
Interventions: DRUG: Patiromer Oral Powder Product
Outcome Measures: Primary: Number of episodes of serum K ≥ 5.5 mEq/L, To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis, 4 weeks | Secondary: Percent of patients with serum K > 5.5 mEq/L, To determine the between-group differences in percent of patients with serum K \> 5.5 mEq/L, 4 weeks|Average dose of patiromer that was given in treatment arm, To determine the efficacy and dosing of patiromer in ESRD patients., 4 weeks|Number of additional hemodialysis treatments due to hyperkalemia., To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia, 4 weeks|Number of significant arrhythmia events as detected with cardiac monitors in Week 4., To determine the between-group differences in pre-specified significant arrhythmia events as detected with cardiac monitors in Week 4., 4 weeks|Difference percentage in serum albumin concentrations., To determine the between-group differences in serum albumin concentrations., 4 weeks|Difference percentage in PTH concentrations., To determine the between-group differences in PTH concentrations., 4 weeks|Number of patients who completed all study visits., To determine feasibility of a large-scale hemodialysis-based trial., 4 weeks|Change percentage in serum potassium concentration two weeks after study drug is discontinued., To determine the change in serum potassium concentration two weeks after study drug is discontinued, 6 weeks|Change percentage in serum phosphorus concentration two weeks after study drug has been discontinued., To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued, 6 weeks|Number of > 1000 PVC/24 hours., Presence of \> 1000 PVC/24 hours, 4 weeks|Number of significant arrhythmias., The between-group and Week-0-to-Week-4-differences in significant arrhythmias will be evaluated., 4 weeks
Sponsor/Collaborators: Sponsor: Duke University | Collaborators: Vifor Pharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2019-06-20
Completion Date: 2023-03-15
Results First Posted:
Last Update Posted: 2023-06-29
Locations: DaVita Dialysis Sites, Durham, North Carolina, 27713, United States
URL: https://clinicaltrials.gov/show/NCT03781089