Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Provide informed consent to participate.
Disqualifiers
Currently treated with and cannot withdraw colchicine due to medical necessity; or
Known allergy/sensitivity to colchicine; or
Prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower; or
Currently pregnant or planning to become pregnant or breastfeed during the study; or
Trial design
Design model
Parallel
Treatments tested in this trial
Colchicine
Drug0.3mg and 0.6mg tablets
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: REPAIR CKD cohortActive comparator 1 intervention
Group B: REPAIR Dialysis cohortActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 17 weeks2
Early discontinuations
Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.
Time frame
Up to 17 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeksOther outcomes
1
Colchicine Concentration
To determine serum concentrations of colchicine achieved at the study doses.
Time frame
Up to 17 weeksSponsors and contacts
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Hamilton Health Sciences Corporation
Lead sponsor
Hamilton Academic Health Sciences Organization
Collaborator
St. Joseph's Health Care London
Collaborator
Source ClinicalTrials.gov