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Low-dose Colchicine for Vascular and Bone Health in CKD

This study is looking at whether a medication called low-dose Colchicine (0.5mg daily) can help improve blood vessel and bone health in people with chronic kidney disease (CKD). You might be able to join if you are 18-69 years old, have CKD stage 3 (eGFR between 30 and 59 ml/min/1.73m2), and also have conditions like high blood pressure, diabetes, high cholesterol, or existing heart disease. The main goal is to see if low-dose Colchicine can reduce calcium buildup in your heart's arteries over 12 months, compared to receiving your usual medical care. This research aims to gather important information for future, larger studies on how to reduce heart problems and bone issues in people with CKD.

Study design
This is a randomized, open-label study involving 60 adults with stage 3 chronic kidney disease. Participants will be randomly assigned to either receive low-dose Colchicine plus usual care or usual care alone.
What's involved
You would have visits at baseline, 1 month (for safety), 6 months, and 12 months for data collection. These visits may include cardiac computed tomography (CCT) scans and blood/urine tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07654231

Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD

Not Yet Recruiting
PHASE2Ages 18–69InterventionalTreatment
University of Texas Southwestern Medical Center
~60 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Low-dose Colchicine at 0.5mg dailyUsual Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Coronary Artery Calcification Agatston Scores
Measured over Baseline, 12 months

Conditions

Chronic Kidney Disease Mineral and Bone Disorder
Hypertension
Diabetes
Dyslipidemia
Atherosclerotic Cardiovascular Disease (ASCVD)
Chronic Kidney Disease (Stage 3)

Explore related trials

AtherosclerosisChronic Kidney DiseaseChronic kidney disease mineral and bone disorderCoronary Artery DiseaseDiabetes MellitusDyslipidemiaHypertensionIschemic StrokePeripheral Artery Disease

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jing Chen, MD · PRINCIPAL_INVESTIGATOR · University of Texas

Who to contact

Alexandra R Hartman
[email protected]
614-420-1186
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Men and women aged 18-\<70 years of all race/ethnicity groups
CKD stage 3 (estimated glomerular filtration rate (eGFR) \>30 to 59 ml/min/1.73m2)
Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
Cardiac artery calcification (CAC) Agatston score ≥30
Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
Ability to provide informed consent.

Exclusion

Current Colchicine therapy
Hepatic disease
Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.
Immunosuppression
Current use of chemotherapy drugs or active cancer
Pregnancy/breastfeeding
Hospitalized within the past 6 months
Allergic/intolerance to colchicine
Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
Human immunodeficiency virus (HIV) infection
Gout attack ≥ 1 time per year
Severe anemia (hemoglobin \< 8 g/dl for women and \< 9 g/dl for men)
eGFR \<30 ml/min/1.73m2
uACR \<200 mg/g
White blood cell count (WBC) \<3.0 x109/L
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x Upper Limit of Normal (ULN)
Total bilirubin \>2 x ULN
Glucose \>300mg/dl
Uses nicotine products or other recreational drugs
Unable to read or speak English
Participant in other conflict clinical trial,
Unable to complete the study measurements
Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
Unsafe to participate in this study per investigator's judgement.

What this trial measures

  • Change in Coronary Artery Calcification Agatston ScoresBaseline, 12 months

    Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols. Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score. Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden). Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.