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NCT02152345 · ClinicalTrials.gov registry record · Phase 4
Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
A Phase 4 study of Implant or Graft; Rejection, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT02152345: Completed Phase 4 study of Implant or Graft; Rejection, sponsored by Columbia University.
NCT02152345 is a Phase 4 study of Implant or Graft; Rejection that has completed, run by Columbia University. The registered enrollment target is 57 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152345, a Phase 4 study of Implant or Graft; Rejection, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.
Primary Outcome
To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen. Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose s
Conditions Studied
Interventions
- DRUG Methylprednisolone
- DRUG Tacrolimus
- DRUG Belatacept
- DRUG Mycophenolate
- DRUG rATG
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 4 |
What the finished NCT02152345 record still lists
NCT02152345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Implant or Graft; Rejection appearing as the primary indexed condition, and to 5 interventions - of which Methylprednisolone is the first listed.
NCT02152345 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02152345 about?
NCT02152345 is a clinical study titled "Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients". The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as...
What is the current status of trial NCT02152345?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2014-06. Estimated completion is 2016-12-31.
What conditions does trial NCT02152345 study?
This clinical trial studies the following conditions: Implant or Graft; Rejection.
What interventions are being tested in trial NCT02152345?
The interventions under investigation include: Methylprednisolone (DRUG), Tacrolimus (DRUG), Belatacept (DRUG), Mycophenolate (DRUG), rATG (DRUG).
Who is sponsoring clinical trial NCT02152345?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02152345 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02152345's enrollment target sits among peer trials
57 1209th of 2000 higher than 789 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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