Colchicine for Kidney Disease

Recruiting at 3 trial locations

Overseen By Jessica Tyrwhitt, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hamilton Health Sciences Corporation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

200 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Michael Walsh, MD, PhD

Principal Investigator

McMaster University

Eligibility Criteria

The REPAIR trial is for people with chronic kidney disease or kidney failure who are experiencing inflammation. Participants must be able to tolerate the medication colchicine and comply with its dosage changes over a period of 16 weeks.

Inclusion Criteria

Provide informed consent to participate

My kidney function is very low but I'm not on dialysis, or I've been on dialysis regularly for the last 3 months.

Exclusion Criteria

I must continue taking colchicine for my health.

I haven't taken strong inhibitors of p-glycoprotein or CYP3A4 in the last 14 days.

Prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open label colchicine 0.3 mg daily for 8 weeks, followed by forced titration to 0.6 mg daily for another 8 weeks if tolerated

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Colchicine

Trial Overview This study tests if colchicine, at doses starting from 0.3 mg daily and potentially increasing to 0.6 mg, can reduce inflammation in patients with different stages of kidney disease over an 8-week period each.

Participant Groups

Group I: REPAIR Dialysis cohort Active Control 1 Intervention

Patients will receive 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.

Group II: REPAIR CKD cohort Active Control 1 Intervention

Patients will receive 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.

Colchicine is already approved in United States for the following indications:

Approved in United States as Colcrys for:

• Gout
• Familial Mediterranean Fever

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

Hamilton Academic Health Sciences Organization

Collaborator

Trials

22

Recruited

5,200+