Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
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.
Description
We will conduct a randomized, open-label, outcome blinded mechanistic clinical trial in 60 adults with stage 3 CKD who have hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD). We will evaluate whether LoDoCo improves CAC and MBD over 12 months in patients with CKD, eGFR ≥30 to 59 mL/min/1.73 m², and uACR ≥200 mg/g. Sixty participants with CKD stage 3 and increased risk of, or established, ASCVD will be randomized 1:1 to receive LoDoCo plus usual care or usual care alone. Primary outcomes include changes in Agaston scores assessed by CCT from ba…
Eligibility
- Age range
- 18–69 years
- Sex
- All
- Healthy volunteers