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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years;

• CKD stage 3b-4 (eGFR 15-44 mL/min/1.73 m2)

• Albumin-creatinine ratio \>30 mg/mmol, or proteinuria \>0.5g/24u, or protein-creatinine ratio \> 50mg/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

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Martin de Borst, prof. dr.
m.h.de.borst@umcg.nl
+31503616161
Backup
Caspar van Lieshout, MD
c.j.van.lieshout@umcg.nl
+31503616161
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 50
Treatments
Experimental: Patiromer
All participants will receive patiromer 8.4g/d (powder for oral suspension) during one of the two 12-week study periods. Following a 6-week washout, participants will switch from the patiromer arm to the placebo arm or vice versa (cross-over design).
Placebo_comparator: Placebo
All participants will receive placebo 8.4g/d (powder for oral suspension) during one of the two 12-week study periods. Following a 6-week washout, participants will switch from the patiromer arm to the placebo arm or vice versa (cross-over design).
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Kidney Foundation, Isala, Health Holland, Amsterdam University Medical Center, Frisius Medisch Centrum, Vifor Pharma, Inc.
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov

Similar Clinical Trials