Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Feb 5, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a medication called patiromer to see if it helps patients with chronic kidney disease (CKD) better tolerate a treatment called irbesartan, which is used for high blood pressure and reducing protein in the urine. The study involves participants who are currently taking a different blood pressure medication and aims to find out if using patiromer allows for a higher dose of irbesartan without raising potassium levels too much. High potassium can be a concern for people with CKD, so the study will monitor potassium levels while testing the effectiveness of patiromer.
To be eligible for this trial, participants must be at least 18 years old and have CKD stage 3b or 4, which means their kidney function is moderately to severely reduced. They should also have high blood pressure or be taking medication for it, and their potassium levels should be within a specific range. During the trial, participants will switch between receiving patiromer and a placebo (a dummy treatment) over two separate 12-week periods. Throughout the study, they will have regular check-ups to monitor their kidney function and potassium levels. This trial is currently recruiting participants, and it’s open to both men and women.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years;
- • CKD stage 3b-4 (eGFR 15-44 mL/min/1.73 m2)
- • Albumin-creatinine ratio \>30 mg/mmol, or proteinuria \>0.5g/24u, or protein-creatinine ratio \> 50mg/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 Criteria:
- • 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);
- • pregnancy or breastfeeding
- • life expectancy \<12 months
- • the 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
About University Medical Center Groningen
University Medical Center Groningen (UMCG) is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research, high-quality patient care, and extensive education in the medical field. As a prominent sponsor of clinical trials, UMCG leverages its multidisciplinary expertise and state-of-the-art facilities to advance medical knowledge and improve therapeutic outcomes. The center fosters collaboration among researchers, healthcare professionals, and industry partners, aiming to translate scientific discoveries into effective treatments that enhance patient health and well-being. With a focus on ethical standards and regulatory compliance, UMCG is dedicated to conducting clinical trials that contribute to the advancement of medicine and the betterment of society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Groningen, , Netherlands
Patients applied
Trial Officials
Liffert Vogt, prof. dr.
Principal Investigator
Amsterdam University Medical Centre
Aaltje Adema, dr.
Principal Investigator
Frisius Medisch Centrum
Femke Waanders, dr.
Principal Investigator
Isala Zwolle
Martin de Borst, prof. dr.
Study Chair
University Medical Center Groningen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported