Chronic Kidney DiseasesPhase 2NCT06203977
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
A Phase 2 study testing Colchicine in people with Chronic Kidney Diseases and Renal Failure, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
Trial summary
Phase 2 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Renal Failure
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesCanada
- Study dates
- 15 Nov 2024to 4 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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:
- white blood cell count < 3.0 X 109/L; or
- platelet count <110 X 109/L; or
- ALT or AST > 3 times the upper limit of normal (ULN); or
- total bilirubin > 2 times ULN and not due to Gilbert syndrome.
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
London Health Sciences Centre
London, Ontario, N6A 5A5
About this study
Phase 2 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.
Read the 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
- Being tested
- Colchicine
- Keywords
- Tolerance, Colchicine Resistance, Hematologic markers
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
0.3mg and 0.6mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Colchicine |
| 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. Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 17 weeks
Early discontinuations
Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.
Measured: Up to 17 weeks
Secondary outcomes (3)
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.
Measured: Up to 17 weeks
Drug adherence
To determine degree of adherence to colchicine at the 0.3 mg and 0.6 mg daily doses.
Measured: 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.
Measured: Up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Nov 2024
- Primary completion4 Apr 2026
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, St. Joseph's Health Care London
- Responsible party
- Sponsor
- Investigators
- Michael Walsh, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203977
- Sponsor's protocol ID
- REPAIR
- Status last verified
- Jul 2026
- First submitted
- 8 Dec 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
- ClinicalTrials.gov ID
- NCT06203977
- Acronym / sponsor ID
- REPAIR
- Conditions
- Chronic Kidney Diseases, Renal Failure
- Keywords
- Tolerance, Colchicine Resistance, Hematologic markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, St. Joseph's Health Care London
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 4 Apr 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 2 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort
| Arm | Type | Receives |
|---|---|---|
| REPAIR CKD cohort | Active comparator | Drug: ColchicinePatients 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 | Drug: ColchicinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine0.3mg and 0.6mg tablets | Drug | REPAIR CKD cohort, REPAIR Dialysis cohort |
Primary outcome
Dose tolerance
Time frame: Up to 17 weeks
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).
Early discontinuations
Time frame: Up to 17 weeks
Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.
3 secondary outcomes
Reason for drug discontinuation
Time frame: Up to 17 weeks
Drug adherence
Time frame: Up to 17 weeks
Major Side Effects
Time frame: Up to 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Walsh, MD, PhD principal investigator
McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Chronic Kidney Diseases and Renal Failure, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose tolerance (time frame: Up to 17 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.