Low-dose Colchicine for Chronic Kidney Disease

(RESOLVE-CKD Trial)

AR
PL
Overseen ByPaola Lanza, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

JC

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

I am between 18 and 69 years old.
I have high blood pressure, diabetes, high cholesterol, or heart/blood vessel disease.
Ability to provide informed consent
See 3 more

Exclusion Criteria

Pregnancy or breastfeeding
Hospitalized within the past 6 months
Allergic or intolerance to colchicine
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-dose Colchicine (LoDoCo) in addition to usual care or usual care alone for 12 months

12 months
In-person visits at baseline, 1 month, 6 months, and 12 months; additional phone assessments as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Low-Dose Colchicine (LoDoCo)Active Control2 Interventions
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+