Tests patiromer to help higher doses of irbesartan in chronic kidney disease
Tests patiromer against placebo to allow higher irbesartan doses in adults with kidney disease.
Plain-language title generated from the registry record
Registry title: Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Key facts
- Where
- Groningen, NetherlandsSee the site
- Phase
- Phase 4
Where in Netherlands
- University Medical Center GroningenGroningen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT06256991
- Record updated
- 19 December 2025
- Original description
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.Read full original descriptionShow less
Potassium Correction for Renin-angiotensin-aldosterone System Optimization in Chronic Kidney Disease
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.
Inclusion: 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; Serum K+ 4.0-5.0 mmol/L; On sub-maximal dose ACEi/ARB.
Exclusion: kidney transplant recipients, or diagnosis of autosomal dominant polycystic kidney disease or other non-glomerular kidney disease; 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; the use of lithium, potassium-sparing diuretics, potassium supplements, trimethoprim or NSAIDS; pregnancy or breastfeeding; life expectancy <12 months.