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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07654231
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Atherosclerotic Cardiovascular Disease (ASCVD)
  • Chronic Kidney Disease (Stage 3)
  • Chronic Kidney Disease Mineral and Bone Disorder
  • Diabetes
  • Dyslipidemia
  • Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-dose Colchicine at 0.5mg daily — DRUG
    Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
  • Usual Care — OTHER
    Participants will receive usual care according to standard clinical practice and treating physician discretion.

Study Details

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.

Key Dates

First listed
Jun 17, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low-Dose Colchicine (LoDoCo)
    Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
  • Active Comparator: Usual Care
    Participants will receive usual care alone.

Primary Outcome Measure

Change in Coronary Artery Calcification Agatston Scores [ Time Frame: Baseline, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Alexandra R Hartman
[email protected]
214-645-8294
Paola Lanza, MD
[email protected]
469-852-9550
Jing Chen, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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