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| Name | Class |
|---|---|
| Hamilton Academic Health Sciences Organization | OTHER |
| St. Joseph's Health Care London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REPAIR CKD cohort | Active Comparator | 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. |
|
| REPAIR Dialysis cohort | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | 0.3mg and 0.6mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Colchicine Concentration | To determine serum concentrations of colchicine achieved at the study doses. | Up to 17 weeks |
Inclusion Criteria:
One of either:
1.2 Estimated GFR using CKD-EPI 2021 equation of ≤30 ml/min/1.73m2 on at least two occasions separated by at least 2 months and do not yet require dialysis and are not expected by their treating nephrologist to require dialysis in the next 6 months (REPAIR CKD cohort), or 1.3 receiving chronic maintenance dialysis 2 or more times per week for the previous 90 days (REPAIR Dialysis cohort);
Age ≥18 years
Provide informed consent to participate.
Exclusion Criteria:
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
Of childbearing potential AND do not have a negative pregnancy test OR do not agree to use two forms of contraception for the duration of the study; or
Anticipated living donor renal transplant within the next 6 months; or
Using a strong inhibitor of p-glycoprotein or strong inhibitor of CYP3A4 in the last 14 days; or
B12 deficiency not managed with intramuscular supplementation; or
Uncontrolled chronic diarrhea; or
Cirrhosis, or chronic active hepatitis; or
Pre-existent neuromuscular disease or persistent serum CK level > 3 times the upper limit of normal as measured within the past 60 days and determined to be non-transient through repeat testing; or
Patient with any of the following within the past 60 days:
Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Christou, BSc | Contact | 905-521-2100 | courtney.christou@phri.ca | |
| Jessica Tyrwhitt, BSc | Contact | jessica.tyrwhitt@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Walsh, MD, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Not yet recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Phase 1 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort
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| 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 |
| St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
|
| London Health Sciences Centre | Not yet recruiting | London | Ontario | N6A 5A5 | Canada |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |