Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)

Chronic Kidney Diseases Clinical Trial

Official title:

Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06203977
• Other study ID #: REPAIR
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Courtney Christou, BSc
• Phone: 905-521-2100
• Email: courtney.christou[@]phri.ca; repair[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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);

2. Age =18 years

3. Provide informed consent to participate.

Exclusion Criteria:

1. Currently treated with and cannot withdraw colchicine due to medical necessity; or

2. Known allergy/sensitivity to colchicine; or

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

4. Currently pregnant or planning to become pregnant or breastfeed during the study; or

5. 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

6. Anticipated living donor renal transplant within the next 6 months; or

7. Using a strong inhibitor of p-glycoprotein or strong inhibitor of CYP3A4 in the last 14 days; or

8. B12 deficiency not managed with intramuscular supplementation; or

9. Uncontrolled chronic diarrhea; or

10. Cirrhosis, or chronic active hepatitis; or

11. 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

12. 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.

13. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Inflammation
• Kidney Diseases
• Renal Failure
• Renal Insufficiency, Chronic

Intervention

Drug:
• Colchicine
0.3mg and 0.6mg tablets

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Hamilton Academic Health Sciences Organization, St. Joseph's Health Care London

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Colchicine Concentration	To determine serum concentrations of colchicine achieved at the study doses.	Up to 17 weeks
Primary	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
Primary	Early discontinuations	Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.	Up to 17 weeks
Secondary	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
Secondary	Drug adherence	To determine degree of adherence to colchicine at the 0.3 mg and 0.6 mg daily doses.	Up to 17 weeks
Secondary	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