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

Starting soon · Phase 2

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

In brief

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.

Key facts

Study ID

NCT07654231

Run by

University of Texas Southwestern Medical Center

People needed

60

Starts

2026-07-01

Expected to finish

2027-12-31

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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