Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Status:
RECRUITING
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
University Medical Center Groningen
Collaborators:
Amsterdam University Medical Center Dutch Kidney Foundation Frisius Medisch Centrum Health Holland Isala Vifor Pharma, Inc.