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NCT01729494 · ClinicalTrials.gov registry record · Phase 4
Belatacept Early Steroid Withdrawal Trial
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 316
- Enrollment target
NCT01729494: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT01729494 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 316 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01729494, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 316 participants
- Enrollment target
Study Summary
The study purpose is to determine the safety and efficacy of a belatacept-based immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit antithymocyte globulin (rATG) induction and early glucocorticoid withdrawal (CSWD) and a belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant recipients. The hypothesis is that a belatacept-based immunosuppressive regimen with alemtuzumab induction, mycophenolate mofetil (MMF)/mycophenolic acid (MPA), and early glucocorticoid withdrawal (Group A) in renal transplant recipients or Belatacept-based immunosuppressive regimen with rabbit antithymocyte globulin induction, MMF/MPA and early glucocorticoid withdrawal (Group B) will lead to less risk of graft loss, patient death, or reduced renal function at 12 months as compared to a tacrolimus-based immunosuppressive regimen with rabbit antithymocyte globulin, MMF/MPA, and early glucocorticoid withdrawal in renal transplant recipients (Group C).
Primary Outcome
Number of Patients who experienced any of the following including patient Death or Graft Loss or had an estimated GFR (eGFR) (MDRD) \< 45 mL/min
Interventions
- DRUG Alemtuzumab
- DRUG Tacrolimus
- DRUG Belatacept
- DRUG Mycophenolate mofetil
- DRUG rabbit antithymocyte globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2012-09 |
| Est. Completion | 2019-12 |
| Phase | Phase 4 |
What the finished NCT01729494 record still lists
NCT01729494 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 5 interventions - of which Alemtuzumab is the first listed.
NCT01729494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01729494 about?
NCT01729494 is a clinical study titled "Belatacept Early Steroid Withdrawal Trial". The study purpose is to determine the safety and efficacy of a belatacept-based immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit antithymocyte globulin (rATG) induction and early glucocorticoid withdrawal (CSWD) and a belatacept-based immunosuppressive regimen with t...
What is the current status of trial NCT01729494?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 316 participants. The study started on 2012-09. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01729494?
The interventions under investigation include: Alemtuzumab (DRUG), Tacrolimus (DRUG), Belatacept (DRUG), Mycophenolate mofetil (DRUG), rabbit antithymocyte globulin (DRUG).
Who is sponsoring clinical trial NCT01729494?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01729494's enrollment target sits among peer trials
316 261st of 2000 higher than 1,740 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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