Recruiting
Phase 2

Colchicine

Sponsor:

Brigham and Women's Hospital

Code:

NCT04500665

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Colchicine

Placebo

Study Details

Brief summary:

This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.

Conditions

Chronic Kidney Diseases

Study ID

NCT04500665

Start date

Nov 1, 2021

Status verified date

Sep, 2025

Completion date

Nov 11, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

A. Inclusion Criteria:

  • Age 21 years to 80 years (inclusive)
  • eGFR of 15 to 75 mL/min per 1.73 m2
  • Urine albumin-to-creatinine ratio of greater than 30 mg/g
  • Use of maximally tolerated doses of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker if urine albumin-to-creatinine ratio greater than 300 mg-g
  • Use of a sodium-glucose co-transporter-2 inhibitor if indicated in the opinion of the participant's primary clinician
  • Willing and able to provide written informed consent and to adhere to the study protocol

B. Exclusion Criteria:

1. History of intolerance or allergy to colchicine
2. Hospitalization for any reason within the previous 30 days
3. Acute condition that requires emergent treatment in the opinion of a physician investigator
4. Stage C or D heart failure according to ACC-AHA criteria77
5. Left ventricular ejection fraction less than 40%
6. Symptomatic valvular heart disease
7. Congenital heart disease (corrected or uncorrected)
8. History of orthotopic heart transplant
9. Kidney failure, defined as kidney transplant recipient or requirement for hemodialysis or peritoneal dialysis
10. Worsening kidney function or acute kidney injury, defined as an increase in serum creatinine of greater than 0.3 mg/dL in the previous 30 days or 50% within the previous 7 days
11. Use of immunosuppressive or anti-inflammatory medications within the previous 30 days, with the exception of less than 5 days of non-steroidal anti-inflammatory drugs or corticosteroids for acute pain or other acute conditions that have since fully resolved provided that the last dose of non-steroid anti-inflammatory drug was at least 7 days before enrollment
12. Familial Mediterranean Fever, gout (unless no flare within the previous 12 months), pericarditis or other indications for colchicine treatment
13. Use of systemic antimicrobial therapy within the previous 30 days or active infection
14. History of respiratory illness that, in the opinion of a physician investigator, may increase the risk of pneumonia
15. Surgery within the previous 30 days or surgery planned to occur within the expected study period
16. Current malignancy or receipt of treatment for malignancy within the previous 1 year
17. Frailty or life-expectancy shortened by comorbidity such as cancer that would increase the participant's risk in the opinion of a physician investigator
18. Neutrophil count < 2,000 cells/mm3
19. Platelet count < 50,000 cells/mm3
20. Concomitant use of a P-gp inhibitor (e.g., cyclosporine, ranolazine, digoxin) and/or moderate-strong CYP3A4 inhibitor (e.g., clarithromycin, indinavir, itraconazole, ritonavir, nefazodone, diltiazem, verapamil, grapefruit juice, fluconazole)
21. Medications that may cause myopathy or rhabdomyolysis (i.e., simvastatin, gemfibrozil, fenofibrate) , a creatine kinase level after the run-in period that exceeds the upper limit of the normal laboratory reference range (if baseline was below the upper limit) or that increases by 50% or more from pre- to post-run-in
22. Moderate-severe hepatic disease (Child-Pugh B or C)
23. Pregnant or unwilling/unable to assure appropriate contraception
24. Breastfeeding

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Colchicine

Colchicine 0.3 mg once daily

placebo comparator: Placebo

Placebo once daily

Interventions

Colchicine

Colchicine

Placebo

Placebo

Primary outcome measure

  • Between-group change in left ventricular global longitudinal strain [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-09-23.