Potassium Correction for RAAS Optimization in Chronic Kidney Disease

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Patiromer 8400 MG [Veltassa]
  • Placebo

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Medical Center Groningen

Lead sponsor

Amsterdam University Medical Center

Collaborator

Frisius Medisch Centrum

Collaborator

Isala

Collaborator

Vifor Pharma, Inc.

Collaborator

Dutch Kidney Foundation

Collaborator

Health Holland

Collaborator