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

The investigators will conduct a randomized, open-label, outcome-blinded, clinical trial in 60 adults with chronic kidney disease (CKD) and existing coronary artery calcification (CAC) Agatston scores of ≥100-1000. Participants will be randomized 1:1 to receive low-dose Colchicine (LoDoCo) plus usual care or usual care alone for 24 months. The primary objective is to evaluate the effect of LoDoCo on CAC progression over 24 months. CAC will be assessed by ECG-gated noncontrast cardiac computed tomography (CT). Outcomes will include Agatston score and calcium volume. The study will estimate variance, baseline-to-follow-up correlations, and other parameters needed to inform future sample size, treatment duration, and endpoint selection. Exploratory objectives include evaluating the effects of LoDoCo on aortic valve and mitral annular calcification, CT-derived vertebral bone mineral density, inflammatory biomarkers, vascular calcification biomarkers, and miner-bone metabolism biomarkers. Additional exploratory analyses will examine cognitive function, Alzheimer's disease biomarkers, peripheral arterial disease measures including ankle-brachial index (ABI) and toe-brachial index (TBI), and kidney outcomes including albumin-creatine ratio (uACR) and estimated glomerular filtration rate (eGFR). Participant experience with LoDoCo will also be evaluated through assessment of treatment acceptability, adherence, adverse effects, and barriers and facilitators to study participation and retention. Participants will be followed at baseline, 6 months, 12 months, 18 months, and 24 months for data collection. Participants assigned to the intervention group will undergo additional safety monitoring, including laboratory assessments, throughout the study period.