Study of Patiromer to Help Increase Irbesartan Dose and Improve Kidney and Blood Pressure Health in Adults with Moderate to Severe Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating whether patiromer can help patients with chronic kidney disease stage 3b4 take higher doses of the drug irbesartan, which affects the renin-angiotensin-aldosterone system RAAS. This study aims to see if patiromer allows for greater irbesartan dosing that leads to significant reductions in albuminuria and blood pressure. The trial is conducted as a randomized, double-blind, placebo-controlled cross-over study to compare patiromer with placebo in this patient group. Participants will first switch from their current ACE inhibitor or angiotensin receptor blocker ARB to a standardized dose of irbesartan 150 mg daily during a 6-week run-in period. Following this, they will complete two 12-week study periods, receiving either patiromer 8.4 g daily or placebo in random order, separated by a 6-week washout period while maintaining irbesartan at 150 mg daily. During each study period, irbesartan will be increased to 300 mg daily, with plasma potassium monitored at 1 and 6 weeks to adjust the dose if potassium levels rise above 5.0 mmolL. Throughout the 36-week participation, participants will undergo regular blood and urine tests, blood pressure measurements both at home and in the clinic, and safety visits involving phone consultations and laboratory checks. These assessments will monitor kidney function, plasma potassium, albuminuria, and blood pressure to evaluate the effects of patiromer and irbesartan dosing. At the end of each treatment period, study medications will be stopped and irbesartan adjusted before the washout and crossover. The primary outcome is the albumin-creatinine ratio at the end of each 12-week treatment period.

Potassium Correction for RAAS Optimization in Chronic Kidney Disease