NCT06256991 Potassium Correction for RAAS Optimization in Chronic Kidney Disease
| NCT ID | NCT06256991 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Medical Center Groningen |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 44 participants in total. It began in 2024-04-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 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) in the last year; * 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
Contact & Investigator
Liffert Vogt, prof. dr.
PRINCIPAL INVESTIGATOR
Amsterdam University Medical Centre
Frequently Asked Questions
Who can join the NCT06256991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06256991 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06256991 currently recruiting?
Yes, NCT06256991 is actively recruiting participants. Contact the research team at m.h.de.borst@umcg.nl for enrollment information.
Where is the NCT06256991 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06256991 clinical trial?
NCT06256991 is sponsored by University Medical Center Groningen. The principal investigator is Liffert Vogt, prof. dr. at Amsterdam University Medical Centre. The trial plans to enroll 44 participants.
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