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

NCT07654231 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-22

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Low-dose Colchicine at 0.5mg daily

Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.

OTHER

Usual Care

Participants will receive usual care according to standard clinical practice and treating physician discretion.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Jing Chen, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-12-01
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07654231 on ClinicalTrials.gov