Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial

Part of paid clinical trials in Dallas, Texas.

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

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

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

Study Details

The overall objective of this pilot randomized clinical trial is to determine whether LoDoCo improves vascular disease including vascular calcification, peripheral arterial disease(PAD), and CKD-MBD biomarkers in patients with 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

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: Intervention Group
    Participants will receive LoDoCo (colchicine 0.5mg) in addition to usual care.
  • Active Comparator: Control Group
    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)

Find similar trials in Dallas, TX

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Texas Southwestern Medical Center· Dallas, TX

Related Studies