BridgeMD
New treatment option for Chronic Kidney Diseases
Official title Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
ClinicalTrials.gov ID: NCT06203977
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 17 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Age ≥18 years
- Provide informed consent to participate.
You likely can't join if
- 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...
- Anticipated living donor renal transplant within the next 6 months; or
See the full eligibility 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...
- Age ≥18 years
- Provide informed consent to participate.
- 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:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 17 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.