PROMISE
Phase 1
Recruiting
- Conditions
- Chronic kidney diseaseTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Age = 18 years; CKD stage 3b-4 (eGFR 15-44 mL/min/1.73 m2 - Albumin-creatinine ratio >30 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
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); pregnancy or breastfeeding; life expectancy <12 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with CKD stage 3b/4, resulting in a significant reduction in albuminuria.;Secondary Objective: The main secondary endpoint is systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period. Further secondary endpoints are plasma potassium levels, kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, the achieved irbesartan dose and the number of (severe) adverse events at the end of each study period.;Primary end point(s): The main trial endpoint is 24-hour urinary albumin excretion, adjusted for creatinine (albumin-creatinine ratio, ACR), at the end of each study period.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):The main secondary endpoint is systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period. Further secondary endpoints are plasma potassium levels, kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, the achieved irbesartan dose and the number of (sever) adverse events at the end of each study period.