Actively Recruiting
Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Led by University Medical Center Groningen · Updated on 2025-12-19
44
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
A
Amsterdam University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years
- Chronic kidney disease stage 3b-4 with eGFR 15-44 mL/min/1.73 m2
- Albumin-creatinine ratio greater than 3 mg/mmol, or proteinuria greater than 0.05 g/24 hours, or protein-creatinine ratio greater than 5 mg/mmol
- Systolic blood pressure greater than 130 mmHg or use of one or more antihypertensive drugs
- Serum potassium level between 4.0 and 5.0 mmol/L
- Currently on sub-maximal dose ACE inhibitor or angiotensin receptor blocker
You will not qualify if you...
- Prior ACEi/ARB dose reduction due to a drop in eGFR by more than 25% in the last year
- History of severe hyperkalemia (greater than 6.0 mmol/L) in the last year
- Pregnancy or breastfeeding
- Life expectancy less than 12 months
- Use of lithium, potassium-sparing diuretics, potassium supplements, trimethoprim, or NSAIDs
- Kidney transplant recipients or diagnosis of autosomal dominant polycystic kidney disease or other non-glomerular kidney disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
M
Martin de Borst, prof. dr.
CONTACT
C
Caspar van Lieshout, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here