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NCT07654231 · ClinicalTrials.gov registry record · Phase 2
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT07654231 is a Phase 2 study that has not yet begun recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 60 participants.
The verdict
NCT07654231, a Phase 2 study, has not yet begun recruiting, sponsored by University of Texas Southwestern Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
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.
Interventions
- OTHER Usual Care
- DRUG Low-dose Colchicine at 0.5mg daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07654231
The ClinicalTrials.gov registry entry for NCT07654231 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT07654231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07654231 about?
NCT07654231 is a clinical study titled "Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD". 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...
What is the current status of trial NCT07654231?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-07-01. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07654231?
The interventions under investigation include: Usual Care (OTHER), Low-dose Colchicine at 0.5mg daily (DRUG).
Who is sponsoring clinical trial NCT07654231?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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