NCT06203977

Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort. Open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.

Detailed description

The REPAIR CKD cohort will enroll 100 patients with chronic kidney disease not requiring dialysis. The REPAIR Dialysis cohort will enroll 100 patients with chronic kidney disease requiring chronic maintenance dialysis. Each participant will be followed for up to 17 weeks, to determine among adults with severe chronic kidney disease not requiring dialysis and (separately) in those requiring dialysis, the proportion who, over 8 weeks of treatment, discontinue colchicine 1) 0.3 mg daily and 2) 0.6 mg daily.

Conditions

• Chronic Kidney Diseases
• Renal Failure

Interventions

Type	Name	Description
DRUG	Colchicine	0.3mg and 0.6mg tablets

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2024-01-12
• Last updated: 2025-03-12

Locations

3 sites across 1 country: Canada