The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.
Successful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.
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
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
Parallel
Low-dose Colchicine at 0.5mg daily
DrugIntervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
Usual Care
Other interventionParticipants will receive usual care according to standard clinical practice and treating physician discretion.
Change in Coronary Artery Calcification Agatston Scores
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.
Change in Coronary Artery Calcification Volume Scores
Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Change in Cardiac Artery Calcification Mass Scores
Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Change in Serum Klotho Levels
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
Change in Fetuin A Levels
Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
eGFR values (mL/min/1.73m2) will be calculated using the NKF-ASN CKD-Epi refit formula.
Exploratory: Change in Ankle-Brachial Index (ABI)
ABI will be measured using semi-automated validated device (simpleABI-600CL). ABI values range from ≤0.90 (Peripheral artery disease), 0.91-0.99 (borderline), 1.00-1.40 (normal). ABI values \>1.40 indicate non-compressible arteries, suggestive of arterial stiffness or medial calcification. Both ABI values ≤0.90 and \>1.40 are associated with worse outcomes.
Exploratory: Change in Toe-Brachial Index (TBI)
TBI will be measured using semi-automated validated device (simpleABI-600CL). TBI values range from ≥0.70 (normal), 0.64-0.69 (borderline), and \<0.40-0.50 (severe distal arterial disease/critical ischemia range). TBI values \<0.70 is a commonly used threshold suggestive of peripheral artery disease. Lower TBI values are associated with worse outcomes.
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