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NCT01810939 · ClinicalTrials.gov registry record · Phase 3
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
A Phase 3 study of Chronic Kidney Disease (CKD) and Hyperkalemia (HK), sponsored by Relypsa.
- Completed
- Registry status
- Phase 3
- Development phase
- 243
- Enrollment target
- 20
- Study locations
NCT01810939: Completed Phase 3 study of Chronic Kidney Disease (CKD) and Hyperkalemia (HK), sponsored by Relypsa.
NCT01810939 is a Phase 3 study of Chronic Kidney Disease (CKD) and Hyperkalemia (HK) that has completed, run by Relypsa. The registered enrollment target is 243 participants, below the 1,399-participant average among 14 other Chronic Kidney Disease (CKD) trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01810939, a Phase 3 study of Chronic Kidney Disease (CKD) and Hyperkalemia (HK), has completed, sponsored by Relypsa.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 243 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Patiromer
Study Locations (20)
Other
- Investigator Site 1103 - Karlovac
- Investigator Site 1102 - Osijek
- Investigator Site 1104 - Zagreb
- Investigator Site 1105 - Zagreb
- Investigator Site 1106 - Zagreb
- Investigator Site 1205 - Znojmo
California
- Investigator Site 3121 - Azusa
- Investigator Site 3133 - Los Angeles
- Investigator Site 3103 - Sacramento
- Investigator Site 3129 - Santa Barbara
- Investigator Site 3130 - Ventura
Florida
- Investigator Site 3105 - Edgewater
- Investigator Site 3113 - Hollywood
- Investigator Site 3106 - Port Charlotte
Missouri
- Investigator Site 3102 - Farmington
- Investigator Site 3104 - Kansas City
Georgia
- Investigator Site 3120 - Augusta
New York
- Investigator Site 3134 - Flushing
Pennsylvania
- Investigator Site 3107 - Bethlehem
Texas
- Investigator Site 3110 - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01810939 record still lists
NCT01810939 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 1,399-participant average among 14 other Chronic Kidney Disease (CKD) trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Chronic Kidney Disease (CKD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01810939 names 20 study sites across 8 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01810939 about?
NCT01810939 is a clinical study titled "A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)". 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 re...
What is the current status of trial NCT01810939?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 243 participants. The study started on 2013-02. Estimated completion is 2013-08.
What conditions does trial NCT01810939 study?
This clinical trial studies the following conditions: Chronic Kidney Disease (CKD), Hyperkalemia (HK).
What interventions are being tested in trial NCT01810939?
The interventions under investigation include: Placebo (DRUG), Patiromer (DRUG).
Who is sponsoring clinical trial NCT01810939?
This trial is sponsored by Relypsa, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01810939 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease (CKD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01810939's enrollment target sits among peer trials
243 8th of 14 higher than 7 of 14 other Chronic Kidney Disease (CKD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease (CKD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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