Clinical Trial

Potassium Correction for RAAS Optimization in Chronic Kidney Disease

Study acronym: PROMISE
Recruiting Phase 4
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Summary
The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b/4. The main questions it aims to answer are: * Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in albuminuria and blood pressure? * Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in blood pressure? The trial contains the following interventions: * Participants will be switched from their ACEi/ARB to a standardised dose of irbesartan (150 mg/d). * During two 12-week study periods, participants will receive either patiromer 8.4 g/d or placebo. The order of study periods is randomized. * At the start of each study period irbesartan will be up-titrated to 300 mg/d. * After 1 and 6 weeks, at both periods, plasma potassium will be measured and the irbesartan dose will be reduced to 150 mg/d in case plasma potassium exceeds 5.0 mmol/L. * At 12 weeks from the start of the study period, the endpoints will be assessed. * Between the two study periods, there is a 6-week washout. Irbesartan dose during the wash-out period will be 150mg/d. After washout, participants will switch from the patiromer arm to the placebo arm or vice versa.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-02-05; most recent amendment 2025-12-12.
Status change: Not Yet Recruiting → Recruiting 2024-06-11
Trial Details
NCT Number NCT06256991
Lead Sponsor University Medical Center Groningen
Collaborators: Amsterdam University Medical Center, Frisius Medisch Centrum, Isala, Vifor Pharma, Inc., Dutch Kidney Foundation, Health Holland
Conditions Chronic Kidney Diseases, Hyperkalemia, Hypertension
Enrollment 44 participants
Start Date 2024-04-01
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-19