| Trial ID: | L0284 |
| Source ID: | NCT06203977
|
| Associated Drug: |
Colchicine
|
| Title: |
Inflammation REduction to Prevent CArdiovascular Injury in Renal Disease (REPAIR)
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Renal Failure
|
| Interventions: |
DRUG: Colchicine
|
| Outcome Measures: |
Primary: Dose tolerance, Proportion of participants who permanently discontinue colchicine at either the 0.3 mg daily dose or 0.6 mg daily dose (to estimate the proportion who would discontinue the study drug at the 0.6 mg daily dose without titration)., Up to 17 weeks|Early discontinuations, Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose., Up to 17 weeks | Secondary: Reason for drug discontinuation, To determine the reasons for temporary and permanent discontinuations of colchicine at the 0.3 mg and 0.6 mg daily doses., Up to 17 weeks|Drug adherence, To determine degree of adherence to colchicine at the 0.3 mg and 0.6 mg daily doses., Up to 17 weeks|Major Side Effects, To determine the risk of major side effects of colchicine at the 0.3 mg and 0.6 mg daily doses., Up to 17 weeks | Other: Colchicine Concentration, To determine serum concentrations of colchicine achieved at the study doses., Up to 17 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hamilton Health Sciences Corporation | Collaborators: Hamilton Academic Health Sciences Organization|St. Joseph's Health Care London
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2024-11-15
|
| Completion Date: |
2026-05-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-12
|
| Locations: |
University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada|St. Joseph's Healthcare Hamilton, Hamilton, Ontario, L8N 4A6, Canada|London Health Sciences Centre, London, Ontario, N6A 5A5, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT06203977
|
