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NCT04786067 · ClinicalTrials.gov registry record · Phase 4
Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
A Phase 4 study of Kidney Transplant Immunosuppression, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04786067: Completed Phase 4 study of Kidney Transplant Immunosuppression, sponsored by University of Texas Southwestern Medical Center.
NCT04786067 is a Phase 4 study of Kidney Transplant Immunosuppression that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04786067, a Phase 4 study of Kidney Transplant Immunosuppression, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy
Primary Outcome
Number of patients with Acute kidney graft rejection confirmed by biopsy by 2017 Banff Criteria. Incidence of biopsy proven acute kidney graft rejection at 12 months after the start of immunosuppression taper
Conditions Studied
Interventions
- DRUG Belatacept
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2025-07-30 |
| Phase | Phase 4 |
What the finished NCT04786067 record still lists
NCT04786067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Kidney Transplant Immunosuppression appearing as the primary indexed condition, and to 1 intervention - of which Belatacept is the first listed.
NCT04786067 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04786067 about?
NCT04786067 is a clinical study titled "Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression". The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell f...
What is the current status of trial NCT04786067?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2021-07-28. Estimated completion is 2025-07-30.
What conditions does trial NCT04786067 study?
This clinical trial studies the following conditions: Kidney Transplant Immunosuppression.
What interventions are being tested in trial NCT04786067?
The interventions under investigation include: Belatacept (DRUG).
Who is sponsoring clinical trial NCT04786067?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04786067 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04786067's enrollment target sits among peer trials
25 1669th of 2000 higher than 303 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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