Phase 3
N=243
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
Chronic Kidney Disease (CKD) · Hyperkalemia (HK)
Bottom Line
View on ClinicalTrials.gov: NCT01810939 ↗Enrolled (actual)
243
Serious AEs
1.1%
Results posted
Dec 2015
Primary outcome: Primary: Change in Serum Potassium From Part A Baseline to Part A Week 4 — -1.01 mEq/L — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Patiromer (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Relypsa, Inc.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Potassium From Part A Baseline to Part A Week 4 |
-1.01 | <0.001 sig |
| PRIMARY Change in Serum Potassium From Part B Baseline |
0.72; 0 | < 0.001 sig |
| SECONDARY Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4 |
76 | — |
| SECONDARY Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B |
60; 15 | <0.001 sig |
| SECONDARY Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B |
91; 43 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Males and females ages 18 - 80
- Chronic kidney disease (CKD) - eGFR 15 to 10.0 %, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the previous 6 months in participants with Type 2 diabetes
- Participants with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Participants with major surgery including thoracic and cardiac, in the past 3 months, or participants with heart or kidney transplant
- Participants with significant cardiovascular or cerebrovascular events in the past 2 months, such as cardiac arrest, myocardial infarction, or stroke
- Participants with BMI ≥ 40 kg/m2
Data sourced from ClinicalTrials.gov (NCT01810939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.