Chronic Kidney DiseasePhase 3COLCHIRENNCT06998862
Colchicine in Chronic Kidney Disease Patients
A Phase 3 study testing colchicine treatment in chronic kidney disease patients in people with Chronic Kidney Disease and Cardiovascular Events, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
The ColchiRen study is a phase 3, controlled, prospective, randomized, double-blind, and multicenter clinical trial. Its main objective is to demonstrate the benefit of low-dose colchicine treatment in secondary prevention of cardiovascular events in patients with moderate CKD. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Kidney Disease, Cardiovascular Events
- What is being tested?
- colchicine treatment in chronic kidney disease patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 744 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2025to 30 Dec 2028
- Phase
- Phase 3
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 99 years. Moderate chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) by the CKD-EPI formula between 30 and 59 mL/min/1.73 m².
- History of a previous cardiovascular event:
- Acute coronary syndrome. Admission for angina pectoris. Transient ischemic attack or non-cardioembolic ischemic stroke. Coronary revascularization. Peripheral vasculopathy, defined as: embolism or acute peripheral arterial ischemia, or the need for amputation or surgical revascularization.
- Finding of coronary artery disease on imaging test.
Who cannot join
- History of allergy or intolerance to colchicine or any of its excipients (dihydrate calcium hydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate).
- Current treatment with colchicine, or within the month prior to inclusion.
- Hospital admission for any cause within the 3 months prior to study inclusion.
- Active malignant neoplasm (except non-melanoma skin cancer or carcinoma in situ). Patients with a history of malignant neoplasm who have remained disease-free for the past 3 years may be included.
- Uncontrolled or symptomatic chronic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, etc.).
- Active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
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- Liver cirrhosis of any cause, grade B or C according to Child-Pugh.
- Immunosuppressive treatment within the 12 weeks prior to study inclusion.
- Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
- Poorly controlled hypertension (>160/90 mmHg) at the time of inclusion.
- Pregnancy and breastfeeding at the time of inclusion. Contraceptive methods are required for women of reproductive age. Women with no capacity for pregnancy are considered to be those with:
- History of hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation.
- Documented infertility. Postmenopausal women, defined as amenorrhea for more than 12 months without other medical cause. In case of doubt, confirmation with elevated follicle-stimulating hormone (FSH) levels is recommended.
- Women of reproductive capacity must use a method of contraception with proven effectiveness until 8 weeks after the end of the study. Acceptable methods include:
- Intrauterine device (IUD) placement at least 6 weeks before study inclusion. Hormonal contraception with progestogens only, associated with ovulation inhibition: oral, injectable, or implantable, at least 6 weeks before study inclusion.
- Progestin-releasing intrauterine system (IUS) at least 6 weeks before study inclusion.
- Combined hormonal contraception (containing estrogen and progestogens) associated with ovulation inhibition: oral, intravaginal, transdermal, at least 6 weeks before study inclusion.
- Other contraceptive methods (sexual abstinence, barrier methods, spermicides, etc.) are not considered acceptable for participation in this study
- Gastric ulcer
- thrombocytopenia <50,000 cells/μL during the month prior to inclusion
- Neutropenia defined as <1500 cells/mcL during the month prior to inclusion.
- Anemia defined as hemoglobin <10.5 g/dL during the month prior to inclusion.
- History of aplastic anemia diagnosed through bone marrow biopsy.
- Treatment with CYP3A4 inhibitors and/or P-glycoprotein inhibitors (antivirals, azole antifungals, aminoglycosides, cyclosporine) in the month prior to their inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28028
Marian Goicoechea, Md, PhD, 0034609838684, marian.goicoechea@gmail.com
About this study
Official title: Efficacy of Colchicine in Secondary Prevention of Vascular Events and Renal Progression in Patients With Moderate Chronic Kidney Disease
The ColchiRen study is a phase 3, controlled, prospective, randomized, double-blind, and multicenter clinical trial. Its main objective is to demonstrate the benefit of low-dose colchicine treatment in secondary prevention of cardiovascular events in patients with moderate CKD. As a secondary objective, it aims to explore the potential beneficial anti-inflammatory effect on the progression of CKD.
Read the detailed description
A total of 744 patients will be included (50% in each branch), and the follow-up time of the study will be three years.
EXPLORATORY PARAMETERS
- Analytical parameters in blood:
- Hemogram: hemoglobin, erythrocyte sedimentation rate.
- Biochemistry: creatinine, glomerular filtration rate estimated by CKD-EPI, glucose, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, uric acid, C-reactive protein, fibrinogen, glycosylated hemoglobin.
- Analytical parameter in urine: albumin/creatinine ratio in first morning urine.
- Parameters in samples centralized in the Renal Pathophysiology Laboratory: array including more than 40 molecules that promote and inhibit inflammation and fibrosis; measurement of ACE and ACE2.
- Cardiovascular events defined as one of the following:
- Cardiovascular death.
- Acute coronary syndrome.
- Angina requiring hospitalization.
- Coronary revascularization.
- Transient ischemic attack or noncardioembolic ischemic stroke.
- Peripheral vascular disease, defined as acute peripheral arterial embolism or ischemia, or need for amputation or percutaneous surgical revascularization.
- Renal event, defined as one of the following:
- 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline.
- Doubling of serum creatinine above baseline.
- Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2.
- Need for renal replacement therapy
- Conditions
- Chronic Kidney Disease, Cardiovascular Events
- Being tested
- colchicine treatment in chronic kidney disease patients, placebo treatment
- 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.
colchicine treatment in chronic kidney disease patientsDrug
colchicine treatment 0.5 mg/day
placebo treatmentDrug
placebo treatment 1 pill/day
| Study group | Role | What they receive |
|---|---|---|
| Colchicine treatment | Active comparator | after randomization, a 0.5 mg tablet of colchicine per day will be administered. Receives: Drug: colchicine treatment in chronic kidney disease patients |
| placebo treatment | Placebo comparator | after randomization 0,25 mg of placebo per day will be administered Receives: Drug: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Incidence of the primary event consisting of death due to cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or non-cardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or the need for amputation or surgical or percutaneous revascularization."
Measured: from enrollment to the end of treamtent at three years
Secondary outcomes (8)
cardiovascular death
Incidence of death due to cardiovascular causes.
Measured: from enrollment to the end of treamtent at three years
Acute coronary syndrome
Incidence of acute coronary syndrome
Measured: from enrollment to the end of treamtent at three years
Angina pectoris
Incidence of hospitalization for angina pectoris.
Measured: from enrollment to the end of treamtent at three years
stroke
Incidence of transient ischemic attack or non-cardioembolic ischemic stroke.
Measured: from enrollment to the end of treamtent at three years
Peripheral vasculopathy
Incidence of peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or the need for amputation or surgical revascularization.
Measured: from enrollment to the end of treamtent at three years
renal disease progression
Individual and combined incidence of renal events:
A 40% decrease in estimated glomerular filtration rate (eGFR) by CKD-EPI compared to baseline, doubling of serum creatinine over its baseline level, Persistent decline in estimated glomerular filtration rate (eGFR) by CKD-EPI below 15 mL/min/1.73 m² or need for sustained renal replacement therapy.
Measured: from enrollment to the end of treamtent at three years
effect of colchcine treatment on inflammation and fibrosis parameters
At the baseline, annual and final visits of the study, an additional blood sample will be obtained, which will be frozen at -80º and sent for centralized analysis at the Renal Physiopathology Laboratory of the Hospital General Universitario Gregorio Marañón. The measurement will be performed using cytokine arrays (Human Inflammation Array, RayBiotech®) with which the measurement of 40 inflammatory/profibrotic and anti-inflammatory factors is contemplated, including among others: TNFα, TNFβ, IL2, IL6, IL7, IL1α, IL1β, IL17A RANTES, ICAM-1, TIMP-1, TIMP-2, GCSF and M-CSF.
Measured: from enrollment to the end of treatment at three years
Security
Incidence of adverse events.
Measured: from enrollment to the end of treatment at three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start12 Feb 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 744 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998862
- Sponsor's protocol ID
- FIBHGM-ECNC002-2022
- Other IDs
- 2023-505868-11-00, 2023
- Acronym
- COLCHIREN
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Colchicine in Secondary Prevention of Vascular Events and Renal Progression in Patients With Moderate Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06998862
- Acronym / sponsor ID
- COLCHIREN / FIBHGM-ECNC002-2022
- Conditions
- Chronic Kidney Disease, Cardiovascular Events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 744 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 31 May 2025 (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.
The ColchiRen study is a phase 3, controlled, prospective, randomized, double-blind, and multicenter clinical trial. Its main objective is to demonstrate the benefit of low-dose colchicine treatment in secondary prevention of cardiovascular events in patients with moderate CKD. As a secondary objective, it aims to explore the potential beneficial anti-inflammatory effect on the progression of CKD.
Detailed description
A total of 744 patients will be included (50% in each branch), and the follow-up time of the study will be three years.
EXPLORATORY PARAMETERS
- Analytical parameters in blood:
- Hemogram: hemoglobin, erythrocyte sedimentation rate.
- Biochemistry: creatinine, glomerular filtration rate estimated by CKD-EPI, glucose, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, uric acid, C-reactive protein, fibrinogen, glycosylated hemoglobin.
- Analytical parameter in urine: albumin/creatinine ratio in first morning urine.
- Parameters in samples centralized in the Renal Pathophysiology Laboratory: array including more than 40 molecules that promote and inhibit inflammation and fibrosis; measurement of ACE and ACE2.
- Cardiovascular events defined as one of the following:
- Cardiovascular death.
- Acute coronary syndrome.
- Angina requiring hospitalization.
- Coronary revascularization.
- Transient ischemic attack or noncardioembolic ischemic stroke.
- Peripheral vascular disease, defined as acute peripheral arterial embolism or ischemia, or need for amputation or percutaneous surgical revascularization.
- Renal event, defined as one of the following:
- 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline.
- Doubling of serum creatinine above baseline.
- Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2.
- Need for renal replacement therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine treatment | Active comparator | Drug: colchicine treatment in chronic kidney disease patientsafter randomization, a 0.5 mg tablet of colchicine per day will be administered. |
| placebo treatment | Placebo comparator | Drug: placebo treatmentafter randomization 0,25 mg of placebo per day will be administered |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 99 years. Moderate chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) by the CKD-EPI formula between 30 and 59 mL/min/1.73 m².
- Acute coronary syndrome. Admission for angina pectoris. Transient ischemic attack or non-cardioembolic ischemic stroke. Coronary revascularization. Peripheral vasculopathy, defined as: embolism or acute peripheral arterial ischemia, or the need for amputation or surgical revascularization.
- Finding of coronary artery disease on imaging test.
Key exclusion criteria (24 listed)
- History of allergy or intolerance to colchicine or any of its excipients (dihydrate calcium hydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate).
- Current treatment with colchicine, or within the month prior to inclusion.
- Hospital admission for any cause within the 3 months prior to study inclusion.
- Active malignant neoplasm (except non-melanoma skin cancer or carcinoma in situ). Patients with a history of malignant neoplasm who have remained disease-free for the past 3 years may be included.
- Uncontrolled or symptomatic chronic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, etc.).
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 |
|---|---|---|
| colchicine treatment in chronic kidney disease patientscolchicine treatment 0.5 mg/day | Drug | Colchicine treatment |
| placebo treatmentplacebo treatment 1 pill/day | Drug | placebo treatment |
Primary outcome
Cardiovascular events
Time frame: from enrollment to the end of treamtent at three years
Incidence of the primary event consisting of death due to cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or non-cardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or the need for amputation or surgical or percutaneous revascularization."
8 secondary outcomes
cardiovascular death
Time frame: from enrollment to the end of treamtent at three years
Acute coronary syndrome
Time frame: from enrollment to the end of treamtent at three years
Angina pectoris
Time frame: from enrollment to the end of treamtent at three years
stroke
Time frame: from enrollment to the end of treamtent at three years
Peripheral vasculopathy
Time frame: from enrollment to the end of treamtent at three years
renal disease progression
Time frame: from enrollment to the end of treamtent at three years
effect of colchcine treatment on inflammation and fibrosis parameters
Time frame: from enrollment to the end of treatment at three years
Security
Time frame: from enrollment to the end of treatment at three years
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 31 May 2025.
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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.
Hospital General Universitario Gregorio Marañon
Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing colchicine treatment in chronic kidney disease patients in people with Chronic Kidney Disease and Cardiovascular Events, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. 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 31 May 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: from enrollment to the end of treamtent at three years). 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 31 May 2025.