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Potassium Correction for RAAS Optimization in Chronic Kidney Disease

RecruitingPhase 4Ages 18 Years - anyAllUniversity Medical Center Groningen
NCT06256991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 bo

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📋 Eligibility rules (as published)
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
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What it tests

  • Patiromer 8400 MG [Veltassa]
  • Placebo
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Where

1 site
University Medical Center Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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