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Not yet taking people in United StatesPhase 2

Low-dose colchicine to slow artery calcium buildup in chronic kidney disease

Tests low-dose colchicine against usual care in adults with kidney disease and heart artery calcium.

Key facts

Who runs it
University of Texas Southwestern Medical Center
Where
Dallas, United StatesSee the site
Trial code
Registry title
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Status
Not yet recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
30 Oct 2026
Expected to end
1 May 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Low-dose Colchicine at 0.5mg daily
  • Usual Care
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 30 to under 70 with chronic kidney disease and calcium build-up in the heart arteries. It tests low-dose colchicine added to usual care.

Age
30 to under 70 years
Sex
Men and women
Disease stage
Chronic kidney disease stage 3 (eGFR 30 to <60 ml/min/1.73m2), or eGFR 60 or higher with urine albumin-to-creatinine ratio of 30 mg/g or more. Heart artery calcification (Agatston score) of 100 to 1000.
Earlier treatment
People currently taking colchicine cannot join. People using immunosuppressive medicines, P-glycoprotein inhibitors or strong CYP3A4 inhibitors cannot join.
Biomarker or test result
Agatston calcium score of 100 to 1000 on heart CT. Kidney function by eGFR and urine albumin-to-creatinine ratio as above.

Main reasons for not taking part

  • Current colchicine use, or allergy or intolerance to colchicine
  • Liver disease, or established peripheral arterial disease
  • Severe heart failure (NYHA class III or IV)
  • HIV infection, active cancer or chemotherapy, or immunosuppression
  • Pregnancy or breastfeeding, or a hospital stay in the past 6 months

The registry criteria, word for word

Show all 33 criteriaShow less

Who can take part

  • Men and women aged 30-<70 years of all race/ethnicity groups
  • Chronic kidney disease (CKD) stage 3 (estimated glomerular filtration rate (eGFR) 30 to <60 ml/min/1.73m2) or eGFR ≥60 and Urine albumin-to-creatinine ratio (uACR) ≥ 30 mg/g
  • Cardiac artery calcification (CAC) Agatston score ≥100-1000
  • Ability to provide informed consent

Who cannot take part

  • 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
  • Immunosuppression, including the use of immunosuppressive medications
  • 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 recreational drugs
  • Hepatic disease
  • Established peripheral arterial disease (PAD) defined by self-report or ICD-10 codes
  • Congestive heart failure classified as New York Heart Association (NYHA) Functional class III or IV
  • Uncontrolled atrial fibrillation with resting heart rate > 100 beats/min
  • Dementia defined by self-report or ICD-10 codes (F01-F03)
  • Alzheimer's disease defined by self-report or ICD-10 codes (G30)
  • Current use of chemotherapy drugs or active cancer
  • Allergic/intolerance to colchicine
  • Human immunodeficiency virus (HIV) infection
  • 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 x10\^9/L
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
  • Total bilirubin >2 x ULN
  • Glucose >300mg/dL
  • Pregnancy/breastfeeding
  • Hospitalized within the past 6 months
  • Gout attack ≥ 1 time per year
  • Participant in other conflict clinical trial
  • Unable to complete the study measurements
  • Unable to undergo to computed tomography (CT)
  • Unsafe to participate in this study per investigator's judgement
  • Unable to read and speak English or Spanish

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 30 and 69 years old?

Where in United States

  • University of Texas Southwestern Medical CenterDallas, United StatesContact: Alexandra R HartmanNot yet recruiting

About the trial

What the trial wants to find out

This pilot randomized, open-label, outcome blinded clinical trial is to evaluate the preliminary effects of low-dose Colchicine (LoDoCo) on coronary artery calcification (CAC) progression in adults with chronic kidney disease (CKD) and existing coronary artery calcification. Sixty participants will be randomized 1:1 to received LoDoCo plus usual care or usual care lone and followed for 24 months.

Read full original descriptionShow less

The primary objective is to evaluate the effect of LoDoCo on CAC progression measured by ECG-gates noncontrast cardiac computed tomography (CT). Exploratory outcomes include valvular calcification, bone mineral density, inflammatory, vascular, and miner-bone biomarkers, cognitive function, Alzheimer's disease biomarkers, peripheral arterial disease measures, kidney biomarkers, and participant-reported measures of treatment acceptability, adherence, and adverse effects.

The 2 groups in the trial

  • Low-Dose Colchicine (LoDoCo)Existing treatment, for comparison

    Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.

    Treatment: Low-dose Colchicine at 0.5mg daily and Usual Care

  • Usual CareExisting treatment, for comparison

    Participants will receive usual care alone.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
Plain-language title
Low-dose colchicine to slow artery calcium buildup in chronic kidney diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07654231, who can take part
Record updated
4 November 2026