NCT07654231Not yet recruitingPhase 2
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University of Texas Southwestern Medical Center
- NCT number
- NCT07654231
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Jul 2026 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current Colchicine therapy
- 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.
- 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)
- Uses nicotine products or other recreational drugs
Other illness
- Hepatic disease
- Current use of chemotherapy drugs or active cancer
- Allergic/intolerance to colchicine
- Human immunodeficiency virus (HIV) infection
Lab values
- Severe anemia (hemoglobin \< 8 g/dl for women and \< 9 g/dl for men)
- eGFR \<30 ml/min/1.73m2
- 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
Other
- Immunosuppression
- Pregnancy/breastfeeding
- Hospitalized within the past 6 months
- Gout attack ≥ 1 time per year
- uACR \<200 mg/g
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.