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NCT07654231

PHASE2

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

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-01

Completion Date

2027-12-31

Last Updated

2026-06-22

Healthy Volunteers

Conditions

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

Interventions

DRUG

Low-dose Colchicine at 0.5mg daily

Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.

OTHER

Usual Care

Participants will receive usual care according to standard clinical practice and treating physician discretion.

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States