At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 243 enrolled
Drug / intervention
Patiromer +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
In Brief
A Phase 3 clinical trial evaluating Patiromer and Placebo for Chronic Kidney Disease (CKD) and Hyperkalemia (HK). Completed, enrolled 243 participants across 58 sites in 10 countries.
Detailed Summary
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease (CKD), Hyperkalemia (HK)
CountriesCroatia, Czechia, Denmark, Georgia, Hungary, Italy, Serbia, Slovenia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedMar 2013
Primary CompletionJul 2013
Study CompletionAug 2013
TodayJul 2026
First PostedMar 14, 2013
Enrollment StartFeb 1, 2013
Primary CompletionJul 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.3 years ago
Interventions
Patiromerdrug
Placebodrug