Colchicine Dosage Impact on Inflammation in Chronic Kidney Disease Patients
This phase 1 study aims to evaluate how well you tolerate different doses of colchicine, a medication used for prevention, and observe any early discontinuations due to side effects, specifically in individuals with chronic kidney disease.
Colchicine
Urogenital Diseases+9
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Prevention Study
Summary
Study start date: November 15, 2024
Actual date on which the first participant was enrolled.This study aims to explore how effective colchicine is in preventing heart-related injuries in people with severe chronic kidney disease. It involves two groups: one with patients whose kidney disease hasn't progressed to the point of needing dialysis, and another with patients who are already on dialysis. Understanding how these patients respond to different doses of colchicine could provide insights into better management of their condition, potentially reducing the risk of cardiovascular issues, which are common in individuals with chronic kidney disease. Participants in the study will be divided into two groups based on their condition. Over a period of 8 weeks, each participant will take colchicine orally, either at a dose of 0.3 mg or 0.6 mg daily, depending on their assigned group. The study's focus is to observe how many participants stop the medication during this period. By closely monitoring the participants' response to the medication, researchers hope to gather valuable data on the tolerability and potential side effects of colchicine in these patient groups.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
St. Joseph's Healthcare Hamilton
Hamilton, CanadaOpen St. Joseph's Healthcare Hamilton in Google MapsUniversity of Alberta Hospital
Edmonton, CanadaLondon Health Sciences Centre
London, Canada