Low-dose colchicine to slow artery calcium buildup in chronic kidney disease

Trial details

Who runs it

University of Texas Southwestern Medical Center

Trial code

NCT07654231

Record updated

4 November 2026

Original description

This pilot randomized, open-label, outcome blinded clinical trial is to evaluate the preliminary effects of low-dose Colchicine (LoDoCo) on coronary artery calcification (CAC) progression in adults with chronic kidney disease (CKD) and existing coronary artery calcification. Sixty participants will be randomized 1:1 to received LoDoCo plus usual care or usual care lone and followed for 24 months.Read full original descriptionShow less

REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)

This pilot randomized, open-label, outcome blinded clinical trial is to evaluate the preliminary effects of low-dose Colchicine (LoDoCo) on coronary artery calcification (CAC) progression in adults with chronic kidney disease (CKD) and existing coronary artery calcification. Sixty participants will be randomized 1:1 to received LoDoCo plus usual care or usual care lone and followed for 24 months.

The primary objective is to evaluate the effect of LoDoCo on CAC progression measured by ECG-gates noncontrast cardiac computed tomography (CT). Exploratory outcomes include valvular calcification, bone mineral density, inflammatory, vascular, and miner-bone biomarkers, cognitive function, Alzheimer's disease biomarkers, peripheral arterial disease measures, kidney biomarkers, and participant-reported measures of treatment acceptability, adherence, and adverse effects.

Inclusion: Men and women aged 30-<70 years of all race/ethnicity groups; Chronic kidney disease (CKD) stage 3 (estimated glomerular filtration rate (eGFR) 30 to <60 ml/min/1.73m2) or eGFR ≥60 and Urine albumin-to-creatinine ratio (uACR) ≥ 30 mg/g; Cardiac artery calcification (CAC) Agatston score ≥100-1000; Ability to provide informed consent.

Exclusion: Current Colchicine therapy; 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, including the use of immunosuppressive medications; 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); Uses recreational drugs; Hepatic disease; Established peripheral arterial disease (PAD) defined by self-report or ICD-10 codes; Congestive heart failure classified as New York Heart Association (NYHA) Functional class III or IV; Uncontrolled atrial fibrillation with resting heart rate > 100 beats/min; Dementia defined by self-report or ICD-10 codes (F01-F03); Alzheimer's disease defined by self-report or ICD-10 codes (G30); Current use of chemotherapy drugs or active cancer; Allergic/intolerance to colchicine; Human immunodeficiency virus (HIV) infection; Severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men); eGFR <30 ml/min/1.73m2; White blood cell count (WBC) <3.0 x10\^9/L; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN); Total bilirubin >2 x ULN; Glucose >300mg/dL; Pregnancy/breastfeeding; Hospitalized within the past 6 months; Gout attack ≥ 1 time per year; Participant in other conflict clinical trial; Unable to complete the study measurements; Unable to undergo to computed tomography (CT); Unsafe to participate in this study per investigator's judgement; Unable to read and speak English or Spanish.

ClinicalTrials.gov NCT07654231