Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Recruiting · NCT06256991 · Interventional (participants receive a specific treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- University Medical Center Groningen - Groningen, Netherlands