Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06256991 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Potassium Correction for RAAS Optimization in Chronic Kidney Disease

Study acronym: PROMISE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 50 to 44 Completion date: Dec 2026 to Dec 2027 · Eligibility criteria expanded, about 4 wordsv4 Show 2 more changesShow less
    • Completion date: Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Apr 2024 to Apr 1, 2024v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2024 to Apr 1, 2024
  3. Study description expanded, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06256991
Lead Sponsor University Medical Center Groningen
Collaborators: Amsterdam University Medical Center, Frisius Medisch Centrum, Isala, Vifor Pharma, Inc., Dutch Kidney Foundation, Health Holland
Conditions Chronic Kidney Diseases, Hyperkalemia, Hypertension
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov