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NCT01856257 · ClinicalTrials.gov registry record · Phase 2
Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT01856257: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01856257 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01856257, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.
Primary Outcome
eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): * A score of ≥90 means kidney function is normal. * A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. * Scores between 30 and 59 indicates moderately reduced kidney function. * Scores between 15 and 29 indicate severely reduced kidney function. * Scores below 15 indicate very severe or end stage kidney failure.
Interventions
- DRUG methylprednisolone
- BIOLOGICAL belatacept
- DRUG mycophenolate mofetil
- BIOLOGICAL basiliximab
- BIOLOGICAL Anti-thymocyte Globulin (Rabbit)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
Why NCT01856257 stopped before completion
NCT01856257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which methylprednisolone is the first listed.
NCT01856257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01856257 about?
NCT01856257 is a clinical study titled "Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen". The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.
What is the current status of trial NCT01856257?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2013-07. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01856257?
The interventions under investigation include: methylprednisolone (DRUG), belatacept (BIOLOGICAL), mycophenolate mofetil (DRUG), basiliximab (BIOLOGICAL), Anti-thymocyte Globulin (Rabbit) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01856257?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01856257's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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