Actively Recruiting
Efficacy of Colchicine in Secondary Prevention of Vascular Events and Renal Progression in Patients With Moderate Chronic Kidney Disease
Led by Hospital General Universitario Gregorio Marañon · Updated on 2025-05-31
744
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of low-dose colchicine treatment in patients with moderate chronic kidney disease (CKD) to prevent cardiovascular events and explore its potential to reduce inflammation and slow CKD progression. This phase 3, randomized, double-blind, multicenter trial aims to include 744 participants and assess both cardiovascular and kidney-related outcomes over three years. Participants are randomly assigned to receive either 0.5 mg of colchicine daily or a placebo pill once per day. The study will track various blood and urine markers related to inflammation, kidney function, and cardiovascular health. Cardiovascular events such as heart attacks, strokes, and peripheral vascular disease, along with kidney events like significant declines in kidney function or the need for dialysis, will be monitored throughout the treatment period. During the study, participants will have blood and urine tests to check kidney function, inflammation, and cardiovascular risk factors. Researchers will measure outcomes including cardiovascular events, kidney disease progression, and safety. The trial includes regular follow-up visits over the three-year treatment period to monitor health and treatment effects, with detailed laboratory analysis centralized in a specialized laboratory to better understand inflammation and fibrosis mechanisms in CKD patients.
CONDITIONS
Brief Title
Colchicine in Chronic Kidney Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 99 years
- Moderate chronic kidney disease with estimated glomerular filtration rate (eGFR) between 30 and 59 mL/min/1.73 m²
- History of previous cardiovascular events such as acute coronary syndrome, angina pectoris, transient ischemic attack, non-cardioembolic ischemic stroke, coronary revascularization, or peripheral vasculopathy
- Evidence of coronary artery disease on imaging tests
You will not qualify if you...
- Allergy or intolerance to colchicine or its excipients
- Current or recent (within 1 month) treatment with colchicine
- Hospital admission for any reason within 3 months before study inclusion
- Active malignant cancer except non-melanoma skin cancer or carcinoma in situ; those disease-free for 3 years may participate
- Uncontrolled or symptomatic chronic inflammatory diseases like rheumatoid arthritis or lupus
- Active infection with hepatitis B, hepatitis C, or HIV
- Liver cirrhosis grade B or C
- Immunosuppressive treatment within 12 weeks prior to inclusion
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Poorly controlled hypertension (>160/90 mmHg) at inclusion
- Pregnancy or breastfeeding; women of reproductive age must use effective contraception until 8 weeks after study ends
- Gastric ulcer
- Low platelet count (<50,000 cells/µL), neutropenia (<1500 cells/mcL), or anemia (hemoglobin <10.5 g/dL) in the month before inclusion
- History of aplastic anemia diagnosed by bone marrow biopsy
- Treatment with CYP3A4 or P-glycoprotein inhibitors (e.g., antivirals, azole antifungals) in the month before inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive daily colchicine or placebo treatment to prevent vascular events and slow kidney disease progression.
Regular visits scheduled throughout treatment period
Trial Site Locations
Total: 1 location
1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28028
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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