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NCT01953120 · ClinicalTrials.gov registry record · Phase 4
Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)
A Phase 4 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01953120: Completed Phase 4 study, sponsored by University of California, Los Angeles.
NCT01953120 is a Phase 4 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01953120, a Phase 4 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the prevention of acute rejection and preservation of kidney function in transplant patients. Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and is being marketed as Nulojix. The pharmaceutical company sponsoring this study is Bristol-Myers Squibb. Belatacept is a prescription medicine used in adults to prevent transplant rejection in people who have received a kidney transplant. Transplant rejection happens when the body's immune system senses that the new transplanted kidney is different or foreign, and attacks it. Belatacept is used with corticosteroids and certain other medicines to help prevent rejection of your new kidney. The purpose of the research is to understand whether the new drug, belatacept, is better than other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used in the treatment against kidney rejection in transplant patients.
Primary Outcome
To analyze the effect of switching from CNI to belatacept in patients with evidence of CNI toxicity on the development and maintenance of immune memory in response to both alloantigen and viral antigens commonly encountered after transplant, and to assess the safety and efficacy of conversion to belatacept as maintenance immunosuppression in combination with prednisone and mycophenolate mofetil.
Interventions
- DRUG Belatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-10 |
| Est. Completion | 2021-04-21 |
| Phase | Phase 4 |
What the finished NCT01953120 record still lists
NCT01953120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Belatacept is the first listed.
NCT01953120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01953120 about?
NCT01953120 is a clinical study titled "Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)". This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the prevention of acute rejection and preservation of kidney function in transplant patients. Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and is being marketed as Nuloj...
What is the current status of trial NCT01953120?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2013-10. Estimated completion is 2021-04-21.
What interventions are being tested in trial NCT01953120?
The interventions under investigation include: Belatacept (DRUG).
Who is sponsoring clinical trial NCT01953120?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01953120's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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