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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
0.3mg and 0.6mg tablets
University of Alberta Hospital
Edmonton, Alberta, Canada
NOT_YET_RECRUITINGSt. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
RECRUITINGLondon Health Sciences Centre
London, Ontario, Canada
NOT_YET_RECRUITINGDose 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).
Time frame: Up to 17 weeks
Early discontinuations
Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.
Time frame: Up to 17 weeks
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.
Time frame: Up to 17 weeks
Drug adherence
To determine degree of adherence to colchicine at the 0.3 mg and 0.6 mg daily doses.
Time frame: 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.
Time frame: Up to 17 weeks
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