Potassium Correction for RAAS Optimization in Chronic Kidney Disease
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,
| Condition(s) | Chronic Kidney Diseases, Hyperkalemia, Hypertension |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 sta |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Medical Center Groningen |
| Locations | Groningen, Netherlands |
| Start date | 2024-04-01 |
| NCT ID | NCT06256991 |
| Official listing | https://clinicaltrials.gov/study/NCT06256991 |