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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 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 316 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01729494
The ClinicalTrials.gov registry entry for NCT01729494 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Alemtuzumab is the first listed.
NCT01729494 reports 0 study locations.
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.
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