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Not 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 69 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Primary outcomes include changes in Agaston scores assessed by cardiac computed tomography (CCT) from baseline to 12 months, second outcomes include changes in the individual biomarkers of MBD and vascular calcification (VC) from baseline and 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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.

Study sites (1)

TX