About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years;
CKD stage 3b-4 (eGFR 15-44 mL/min/1.73 m2)
Albumin-creatinine ratio >3 mg/mmol, or proteinuria >0.05g/24u, or protein-creatinine ratio > 5mg/mmol
Systolic blood pressure >130 mmHg or use of one or more antihypertensive drugs;
Disqualifiers
prior ACEi/ARB dose reduction due to a drop in eGFR by >25% in the last year;
history of severe hyperkalaemia (>6.0 mmol/L) in the last year;
pregnancy or breastfeeding
life expectancy <12 months
Trial design
Treatments tested in this trial
- Patiromer 8400 MG [Veltassa]
- Placebo
Treatment groups
Sponsors and collaborators
University Medical Center Groningen
Lead sponsor
Amsterdam University Medical Center
Collaborator
Frisius Medisch Centrum
Collaborator
Isala
Collaborator
Vifor Pharma, Inc.
Collaborator
Dutch Kidney Foundation
Collaborator
Health Holland
Collaborator