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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: Clinical Trial Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols. Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score. Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden).
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 |
What is known before NCT07654231 opens enrollment
NCT07654231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT07654231 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07654231's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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