Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Chronic Kidney Diseases Clinical Trial

Official title:

Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500665
• Other study ID #: 2020P002468
• Secondary ID: K23HL150311
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: November 11, 2026

Study information

• Verified date: January 2024
• Source: Brigham and Women's Hospital
• Contact: Leo F Buckley, PharmD MPH
• Phone: 617-732-5500
• Email: lfbuckley[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 11, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

A. Inclusion Criteria:

1. Age 21 years to 80 years (inclusive)

2. eGFR of 15 to 75 mL/min per 1.73 m2

3. Urine albumin-to-creatinine ratio of greater than 30 mg/g

7. 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 8. Use of a sodium-glucose co-transporter-2 inhibitor if indicated in the opinion of the participant's primary clinician 9. 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Colchicine
Colchicine
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-group change in left ventricular global longitudinal strain	Assessed using transthoracic echocardiography	4 weeks
Secondary	Between-group change in left ventricular systolic and diastolic function	Assessed using transthoracic echocardiography	4 weeks
Secondary	Between-group change in left ventricular volumes	Assessed using transthoracic echocardiography	4 weeks
Secondary	Between-group change in left ventricular size	Assessed using transthoracic echocardiography	4 weeks
Secondary	Between-group change in systemic inflammation	Assessed using C-reactive protein	4 weeks