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Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial
Sponsor: University of Texas Southwestern Medical Center
Summary
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.
Official title: Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-07-01
Completion Date
2027-12-31
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Low-dose colchicine
Intervention group will receive LoDoCo (colchicine 0.5mg), oral, once daily.
Usual Care
Participants will receive usual care alone according to standard clinical practice and treating physician discretion.
Locations (1)
University of Texas Southwestern Medical Center
Dallas, Texas, United States