Low-dose Colchicine for Chronic Kidney Disease
(RESOLVE-CKD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jing Chen, MD
Principal Investigator
University of Texas
Are You a Good Fit for This Trial?
This trial is for adults aged 18-69 with stage 3 chronic kidney disease, high blood pressure, diabetes, or high cholesterol. Participants must have certain lab results and cannot be pregnant, recently hospitalized, allergic to colchicine, using specific medications, or have severe anemia or liver problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low-dose Colchicine (LoDoCo) in addition to usual care or usual care alone for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low-dose Colchicine
Trial Overview
The study compares low-dose colchicine (0.5mg daily) plus usual care versus usual care alone in people with CKD stage 3 over one year to see if it improves blood vessel and bone health markers.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
Participants will receive usual care alone.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
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