Investigating potassium correction and RAAS optimisation
The PROMISE study investigates whether patiromer can enable optimisation of irbesartan treatment in people with chronic kidney disease. This page presents information about the research, eligibility criteria and participating centres.
NEFRO-NL • Study portfolio for professionals
Potassium Correction for RAAS Optimization in Chronic Kidney Disease (PROMISE)
Study summary
PROMISE is a randomized, double-blind, placebo-controlled crossover study evaluating whether potassium lowering with patiromer permits optimization of RAAS blockade using irbesartan in patients with CKD stage 3b/4. Participants receive patiromer and placebo in two 12-week treatment periods separated by a 6-week washout period.
Which patients may be eligible?
Key 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 >50 mg/24u, or protein-creatinine ratio > 5 mg/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
Key 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 of less than 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.
Eligibility is assessed exclusively by the treating physician or study team.
About this study
Study aim
To determine whether patiromer enables safe up-titration of irbesartan in CKD stage 3b/4 patients, resulting in improved albuminuria and blood pressure control compared with placebo.
Intervention / treatment
Patiromer 8400 MG [Veltassa]
Study design
Phase IV, randomized, double-blind, placebo-controlled, crossover interventional trial.
Trial duration per participant
36 weeks
Participating centres
UMCG
Relevant links
Contact NEFRO-NL
How can we help you?
Would you like to learn more about NEFRO-NL, our research network or our services? Our project managers are happy to help. Contact us at info@nefro-nl.nl.
Antina de Boer
Project Manager
