Not Yet RecruitingPhase 2

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

United States60 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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/…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 pilot trial that hasn't started recruiting yet — given that early-phase trials are still establishing safety and dosing, how confident are you that low-dose colchicine would be safe for someone with Stage 3 CKD, since the kidneys play a big role in clearing that drug?
2The trial is measuring changes in coronary artery calcification scores — does that mean my current level of arterial calcification would need to be assessed first, and would that information be useful for my care even outside of this trial?
3Since I also have conditions like hypertension, diabetes, or dyslipidemia listed in this trial, are there standard treatments already proven to help with those that I should be trying or optimizing before considering an experimental approach?
4Because this study isn't recruiting yet, what's your sense of the timeline before it might open, and in the meantime are there other ways to manage my cardiovascular and bone risks related to CKD mineral and bone disorder?
5Colchicine is already used for other conditions like gout and heart inflammation — can you help me understand whether the potential benefit of reducing inflammation to protect my blood vessels and bones is something that applies to my specific situation, based on what this trial is trying to find out?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Coronary Artery Calcification Agatston Scores

Timeframe: Baseline, 12 months

Trial details

NCT IDNCT07654231

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Alexandra R Hartman

614-420-1186 RESOLVE-CKD@UTSouthwestern.edu

View on ClinicalTrials.gov More Chronic Kidney Disease Mineral and Bone Disorder trials