Chronic Kidney DiseasesPhase 2NCT04500665
Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine
A Phase 2 study testing Colchicine in people with Chronic Kidney Diseases, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 11 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
- Exclusion Criteria:
- History of intolerance or allergy to colchicine
- Hospitalization for any reason within the previous 30 days
- Acute condition that requires emergent treatment in the opinion of a physician investigator
- Stage C or D heart failure according to ACC-AHA criteria77
- Left ventricular ejection fraction less than 40%
- Symptomatic valvular heart disease
- Congenital heart disease (corrected or uncorrected)
- History of orthotopic heart transplant
- Kidney failure, defined as kidney transplant recipient or requirement for hemodialysis or peritoneal dialysis
- 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
- 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
- Familial Mediterranean Fever, gout (unless no flare within the previous 12 months), pericarditis or other indications for colchicine treatment
- Use of systemic antimicrobial therapy within the previous 30 days or active infection
- History of respiratory illness that, in the opinion of a physician investigator, may increase the risk of pneumonia
- Surgery within the previous 30 days or surgery planned to occur within the expected study period
- Current malignancy or receipt of treatment for malignancy within the previous 1 year
- Frailty or life-expectancy shortened by comorbidity such as cancer that would increase the participant's risk in the opinion of a physician investigator
- Neutrophil count < 2,000 cells/mm3
- Platelet count < 50,000 cells/mm3
- 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)
- 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
- Moderate-severe hepatic disease (Child-Pugh B or C)
- Pregnant or unwilling/unable to assure appropriate contraception
- Breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Leo Buckley, PharmD, 617-732-4497, lfbuckley@bwh.harvard.edu
About this study
This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Colchicine, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Colchicine 0.3 mg once daily Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group change in left ventricular global longitudinal strain
Assessed using transthoracic echocardiography
Measured: 4 weeks
Secondary outcomes (4)
Between-group change in left ventricular systolic and diastolic function
Assessed using transthoracic echocardiography
Measured: 4 weeks
Between-group change in left ventricular volumes
Assessed using transthoracic echocardiography
Measured: 4 weeks
Between-group change in left ventricular size
Assessed using transthoracic echocardiography
Measured: 4 weeks
Between-group change in systemic inflammation
Assessed using C-reactive protein
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Nov 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Leo F. Buckley, PharmD, Brigham and Women's Hospital
- Investigators
- Leo F Buckley, PharmD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500665
- Sponsor's protocol ID
- 2020P002468
- Other IDs
- K23HL150311
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine
- ClinicalTrials.gov ID
- NCT04500665
- Acronym / sponsor ID
- 2020P002468
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the efficacy and safety of colchicine in patients with chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineColchicine 0.3 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine | Drug | Colchicine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Between-group change in left ventricular global longitudinal strain
Time frame: 4 weeks
Assessed using transthoracic echocardiography
4 secondary outcomes
Between-group change in left ventricular systolic and diastolic function
Time frame: 4 weeks
Between-group change in left ventricular volumes
Time frame: 4 weeks
Between-group change in left ventricular size
Time frame: 4 weeks
Between-group change in systemic inflammation
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leo F Buckley, PharmD MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Chronic Kidney Diseases, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leo F Buckley, PharmD MPH (617-732-5500, lfbuckley@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group change in left ventricular global longitudinal strain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.