Colchicine for Kidney Disease

Recruiting at 3 trial locations

Overseen By Jessica Tyrwhitt, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hamilton Health Sciences Corporation

Must not be taking: Colchicine, P-glycoprotein inhibitors

Disqualifiers: Pregnancy, Cirrhosis, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests colchicine to determine its effectiveness for people with different stages of kidney disease. It includes two groups: one for individuals with chronic kidney disease (CKD) who do not yet require dialysis, and another for those already undergoing dialysis. Participants will take colchicine daily, beginning with a low dose that may increase if tolerated. The trial seeks individuals with low kidney function or those on regular dialysis. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using a strong inhibitor of p-glycoprotein or CYP3A4 in the last 14 days. It's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that colchicine can be safe for people with severe chronic kidney disease (CKD). One study found that patients with severe CKD who took lower doses of colchicine for arthritis flare-ups experienced good results, with most of the 54 participants tolerating the treatment well. However, limited research exists specifically on colchicine's safety for people with severe CKD, as many clinical trials often exclude these patients. While some evidence suggests safety, more research is needed to fully understand colchicine's safety for all kidney disease patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Colchicine is unique in the treatment of kidney disease because it offers a novel approach compared to standard treatments like ACE inhibitors or angiotensin receptor blockers, which primarily focus on blood pressure and protein levels. Colchicine works by targeting inflammation at the cellular level, which could address the root causes of kidney damage more directly. Researchers are excited about its potential to improve kidney function by reducing inflammation, possibly slowing down disease progression in a way that current treatments do not.

What evidence suggests that colchicine might be an effective treatment for kidney disease?

This trial will evaluate colchicine's effects on kidney disease. Research has shown that colchicine effectively treats a type of arthritis caused by crystal buildup, even in individuals with severe chronic kidney disease (CKD). In one study, 83% of these patients experienced relief with colchicine. Other studies suggest that colchicine may also lower the risk of major heart problems, such as heart attacks, by reducing inflammation. However, limited information exists on colchicine's direct impact on kidney function, as previous studies did not focus on this aspect. Despite this, colchicine has generally been well-tolerated by people with CKD, with some experiencing mild side effects like diarrhea. ^{2 3 6 7 8}

Who Is on the Research Team?

Michael Walsh, MD, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provide informed consent to participate

My kidney function is very low but I'm not on dialysis, or I've been on dialysis regularly for the last 3 months.

Exclusion Criteria

I must continue taking colchicine for my health.

I haven't taken strong inhibitors of p-glycoprotein or CYP3A4 in the last 14 days.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open label colchicine 0.3 mg daily for 8 weeks, followed by forced titration to 0.6 mg daily for another 8 weeks if tolerated

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Colchicine

Trial Overview 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.

How Is the Trial Designed?

Group I: REPAIR Dialysis cohort Active Control 1 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 cohort Active Control 1 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.

Colchicine is already approved in United States for the following indications:

Approved in United States as Colcrys for:

• Gout
• Familial Mediterranean Fever

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

Hamilton Academic Health Sciences Organization

Collaborator

Trials

22

Recruited

5,200+

Citations

1. rmdopen.bmj.com rmdopen.bmj.com/content/10/1/e003872

Safety and efficacy of colchicine in crystal-induced arthritis ... The use of colchicine, at reduced dosage, in patients with crystal-induced arthritis flare and severe CKD was effective (83%) and well tolerated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10550007/

Management of Patients with Gout and Kidney Disease Prior randomized clinical trials (RCTs) for colchicine in CKD did not report outcomes on the basis of renal function; thus, there is a lack of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06998862

Colchicine in Chronic Kidney Disease Patients Its main objective is to demonstrate the benefit of low-dose colchicine treatment in secondary prevention of cardiovascular events in patients with moderate ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11997804/

Effects of anti-inflammatory agents on clinical outcomes in ... Some cardiovascular outcome trials have shown improvements in major adverse cardiac events (MACE) with the use of anti-inflammatory therapies such as colchicine ...

5. rheumatologyadvisor.com rheumatologyadvisor.com/home/topics/gout/low-dose-colchicine-effective-for-managing-cppd-disease-flares-in-severe-ckd/

Low-Dose Colchicine Well Tolerated for Managing Crystal ... The investigators deemed colchicine fully effective in 83% of patients. Clinician-reported adverse events included diarrhea (13%), vomiting (5%) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38296804/

Safety and efficacy of colchicine in crystal-induced arthritis ... The use of colchicine, at reduced doses, was mostly effective to treat crystal-induced arthritis flare in 54 patients with severe CKD and was well tolerated.

7. bhm.scholasticahq.com bhm.scholasticahq.com/article/123647-complications-of-colchicine-initiation-in-a-patient-with-chronic-kidney-disease

Complications Of Colchicine Initiation in a Patient with Chronic ... Unfortunately, research into the safety of colchicine in patients with severe CKD is lacking, as most clinical trials exclude patients with CrCl ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa2021372

Colchicine in Patients with Chronic Coronary Disease An independent data and safety monitoring board reviewed cumulative safety data to safeguard the well-being of the patients. Full details of the trial ...