| Trial ID: | L0273 |
| Source ID: | NCT06256991
|
| Associated Drug: |
Patiromer 8400 Mg [Veltassa]
|
| Title: |
Potassium Correction for RAAS Optimization in Chronic Kidney Disease
|
| Acronym: |
PROMISE
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Hyperkalemia|Hypertension
|
| Interventions: |
DRUG: Patiromer 8400 MG [Veltassa]|DRUG: Placebo
|
| Outcome Measures: |
Primary: Albumin-creatinine ratio (ACR), The primary study endpoint is the difference in ACR in 24-hour urine at the end of each study visit, compared to the ACR at the start of the study period. This is a continuous variable that will be presented quantitatively. In case of non-normal distribution, this parameter will be log-transformed. The primary hypothesis test will be the difference between placebo and treatment groups after 2 periods., At the end of both 12-week study periods (patiromer and placebo) | Secondary: Blood pressure, Systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period (continuous data), At the end of both 12-week study periods (patiromer and placebo)|Plasma potassium, Plasma potassium level at the end of each study period (continuous data), At the end of both 12-week study periods (patiromer and placebo)|Kidney function, Kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, at the end of each study period (continuous data), At the end of both 12-week study periods (patiromer and placebo)|Irbesartan dose, Irbesartan dose at the end of each study period (continuous data), At the end of both 12-week study periods (patiromer and placebo)|Adverse events, Numbers of AE/SAE during each study period (count data), At the end of both 12-week study periods (patiromer and placebo)
|
| Sponsor/Collaborators: |
Sponsor: University Medical Center Groningen | Collaborators: Amsterdam University Medical Center|Medical Centre Leeuwarden|Isala|Vifor Pharma, Inc.|Dutch Kidney Foundation|Health Holland
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-04-01
|
| Completion Date: |
2026-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-12
|
| Locations: |
University Medical Center Groningen, Groningen, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT06256991
|
