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RESOLVE-CKDNCT07654231

REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved 1 year 5 months later, primary endpoint(s) modified.

See at-risk trials from University of Texas Southwestern Medical Center

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to May 1, 2029 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Jul 1, 2026 to Oct 30, 2026
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints shortened, about 138 words
    • Study description expanded, about 30 words
    • Publications: 37 to 41
    • Study title expanded, about 6 words
  2. Eligibility criteria expanded, about 35 words
    • Interventions: Low-dose colchicine (Drug), Usual Care (Other) to Low-dose Colchicine at 0.5mg daily (Drug), Usual Care (Other)
    • Study description expanded, about 30 words
    • Study title shortened, about 5 words
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Change in Coronary Artery Calcification Agatston Scores
Timeframe: Baseline, 12 months, 24 months
Change in Coronary Artery Calcification Volume Scores
Timeframe: Baseline, 12 months, 24 months

Arms and interventions

Low-Dose Colchicine (LoDoCo)Active comparator

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

Usual CareActive comparator

Participants will receive usual care alone.

Drugs: Low-dose Colchicine at 0.5mg daily

Other: Usual Care

Sites

1 site in 1 country

  • University of Texas Southwestern Medical CenterDallas, Texas, United States