Phase 2
N=295
Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
Hyperkalemia · Resistant Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03071263 ↗Enrolled (actual)
295
Serious AEs
1.7%
Results posted
Jan 2020
Primary outcome: Primary: Number of Participants Remaining on Spironolactone at Week 12 — 126; 98 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Patiromer (Drug); Placebo (Drug); Spironolactone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Relypsa, Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Remaining on Spironolactone at Week 12 |
126; 98 | <0.0001 sig |
| SECONDARY Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications |
-11.3; -11.0 | 0.5757 |
Summary
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Taking at least three medications for blood pressure (one a diuretic)
- Uncontrolled high blood pressure
- Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45 mL/min/1.73m2
- Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)
Exclusion Criteria
- History of untreated known causes of high blood pressure, excluding kidney disease (not CKD)
- Inability to measure BP
- Not taking high blood pressure medications as prescribed medications
- Recent change in renal function (in the past 3 months) which has required hospitalization or dialysis
- Renal transplant
- History of cancer within past 12 months
- Recent cardiovascular event with last 3 months
- Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial fibrillation with uncontrolled heart rate)
- Inability to take study medication
- Alcoholism
Data sourced from ClinicalTrials.gov (NCT03071263). 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.