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Anti-inflammatory agent

REPAIR Dialysis cohort for Kidney Failure

Phase 1

Waitlist Available

Led By Michael Walsh, MD, PhD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 17 weeks

Awards & highlights

Study Summary

This trial is divided into two groups: one for patients with chronic kidney disease (CKD) and one for patients on dialysis. The patients in both groups will take colchicine, starting with

Who is the study for?

The REPAIR trial is for people with chronic kidney disease or kidney failure who are experiencing inflammation. Participants must be able to tolerate the medication colchicine and comply with its dosage changes over a period of 16 weeks.Check my eligibility

What is being tested?

This study tests if colchicine, at doses starting from 0.3 mg daily and potentially increasing to 0.6 mg, can reduce inflammation in patients with different stages of kidney disease over an 8-week period each.See study design

What are the potential side effects?

Colchicine may cause side effects like gastrointestinal discomfort (e.g., diarrhea, nausea), blood disorders, muscle pain or weakness, and could interact with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 17 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 17 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose tolerance

Early discontinuations

Secondary outcome measures

Drug adherence

Major Side Effects

Reason for drug discontinuation

Other outcome measures

Colchicine Concentration

Trial Design

2Treatment groups

Active Control

Group I: REPAIR Dialysis cohortActive Control1 Intervention

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.

Group II: REPAIR CKD cohortActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Joseph's Health Care LondonOTHER

27 Previous Clinical Trials

2,298 Total Patients Enrolled

Hamilton Academic Health Sciences OrganizationOTHER

20 Previous Clinical Trials

4,666 Total Patients Enrolled

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,793 Total Patients Enrolled

1 Trials studying Kidney Failure

220 Patients Enrolled for Kidney Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"According to the information provided on clinicaltrials.gov, this particular trial is not currently enrolling patients. It was first posted on March 1st, 2024 and last updated on January 10th, 2024. However, it's worth noting that there are numerous other active clinical trials seeking participants at this time, with a total of 856 studies available for enrollment."

Answered by AI

Has the REPAIR Dialysis cohort received official authorization from the FDA?

"Given that this is a Phase 1 trial with limited safety and efficacy data, our team at Power assigns a safety rating of 1 to the REPAIR Dialysis cohort."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06203977.