RecruitingPhase 4NCT06256991

Potassium Correction for RAAS Optimization in Chronic Kidney Disease

Potassium Correction for Renin-angiotensin-aldosterone System Optimization in Chronic Kidney Disease

Sponsor

University Medical Center Groningen

Enrollment

44 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Hypertension Chronic Kidney Diseases Hyperkalemia

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether correcting potassium levels in the blood can allow people with chronic kidney disease (CKD) to take higher doses of blood pressure medications called ACE inhibitors or ARBs — which are known to protect the kidneys but are sometimes limited by rising potassium levels. **You may be eligible if...** - You are 18 or older - You have moderate-to-advanced CKD (stage 3b or 4, meaning your kidneys are functioning at reduced capacity) - You have protein in your urine (a sign of kidney damage) - Your blood pressure is elevated, or you are already taking blood pressure medications - Your blood potassium level is between 4.0 and 5.0 mmol/L - You are currently on a lower-than-maximum dose of an ACE inhibitor or ARB **You may NOT be eligible if...** - Your ACE inhibitor or ARB was previously reduced because it caused your kidney function to drop sharply - You had dangerously high potassium (above 6.0 mmol/L) in the past year - You are pregnant or breastfeeding - Your life expectancy is less than 12 months - You take lithium, potassium-sparing water pills, potassium supplements, trimethoprim, or NSAIDs (like ibuprofen) - You have had a kidney transplant or have polycystic kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPatiromer 8400 MG [Veltassa]

Patiromer is a cation-exchanging polymer intended for oral intake that is not resorbed from the gastro-intestinal tract. Patiromer has been approved by the European Medicines Agency (EMA) and is available for clinical use in The Netherlands for the indication of hyperkalemia in adults. It contains calcium-sorbitol complex as a counter-ion. Patiromer increases the faecal excretion of potassium in the gastro-intestinal lumen by exchange with part of the calcium. This results in a lower concentration of free potassium in the gastro-intestinal lumen, reducing in turn plasma potassium concentration. After initiation of patiromer, a clinically significant reduction in plasma potassium can be observed at around 7 hours, the effect persists for approximately 24 hours. Patiromer is excreted by the fecal route, 24-48 hrs after ingestion. Since patiromer is not absorbed or metabolized by the body, other drugs are not expected to influence the efficacy of patiromer.

DRUGPlacebo

Placebo is a powder with a similar appearance, smell, and taste as patiromer, but without and clinically detectable effects. It is intended for oral intake.