Actively Recruiting
Potassium Correction for Renin-angiotensin-aldosterone System Optimization in Chronic Kidney Disease
Led by University Medical Center Groningen · Updated on 2025-12-19
44
Participants Needed
1
Research Sites
52 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
Researchers are evaluating whether patiromer can help patients with chronic kidney disease stage 3b/4 take higher doses of the drug irbesartan, which affects the renin-angiotensin-aldosterone system (RAAS). This study aims to see if patiromer allows for greater irbesartan dosing that leads to significant reductions in albuminuria and blood pressure. The trial is conducted as a randomized, double-blind, placebo-controlled cross-over study to compare patiromer with placebo in this patient group. Participants will first switch from their current ACE inhibitor or angiotensin receptor blocker (ARB) to a standardized dose of irbesartan 150 mg daily during a 6-week run-in period. Following this, they will complete two 12-week study periods, receiving either patiromer 8.4 g daily or placebo in random order, separated by a 6-week washout period while maintaining irbesartan at 150 mg daily. During each study period, irbesartan will be increased to 300 mg daily, with plasma potassium monitored at 1 and 6 weeks to adjust the dose if potassium levels rise above 5.0 mmol/L. Throughout the 36-week participation, participants will undergo regular blood and urine tests, blood pressure measurements both at home and in the clinic, and safety visits involving phone consultations and laboratory checks. These assessments will monitor kidney function, plasma potassium, albuminuria, and blood pressure to evaluate the effects of patiromer and irbesartan dosing. At the end of each treatment period, study medications will be stopped and irbesartan adjusted before the washout and crossover. The primary outcome is the albumin-creatinine ratio at the end of each 12-week treatment period.
CONDITIONS
Brief Title
Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic kidney disease stage 3b or 4 with eGFR between 15 and 44 mL/min/1.73 m2
- Albumin-creatinine ratio greater than 3 mg/mmol, or proteinuria over 0.05 g/24 hours, or protein-creatinine ratio over 5 mg/mmol
- Systolic blood pressure above 130 mmHg or use of one or more antihypertensive medications
- Serum potassium between 4.0 and 5.0 mmol/L
- Currently on a sub-maximal dose of ACE inhibitor or angiotensin receptor blocker (ARB)
You will not qualify if you...
- Prior dose reduction of ACE inhibitor or ARB due to a drop in eGFR by more than 25% in the past year
- History of severe hyperkalemia (above 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 diseases
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants switch to irbesartan 150 mg once daily or remain on this dose if already using it, to stabilize before starting treatment periods.
1 baseline visit at the end of the run-in period
Duration - 12 weeks
Participants receive either patiromer or placebo for 12 weeks while continuing irbesartan. Safety and blood pressure monitoring occur during this period.
Home blood pressure measurement and local lab visit 1 week after start, phone consultation, in-hospital visit at 6 weeks, and end-of-period visit
Duration - 6 weeks
Participants stop study medication and maintain irbesartan dose to avoid carry-over effects before the second treatment period.
No scheduled visits
Duration - 12 weeks
Participants cross over to the other study medication (patiromer or placebo) for another 12-week period with similar monitoring as the first treatment period.
Home blood pressure measurement and local lab visit 1 week after start, phone consultation, in-hospital visit at 6 weeks, and end-of-period visit
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
M
Martin de Borst, prof. dr.
C
Caspar van Lieshout, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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