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NCT01921218 · ClinicalTrials.gov registry record · Phase 3
Belatacept Therapy for the Failing Renal Allograft
A Phase 3 study of Failing Renal Allograft, sponsored by Andrew B Adams.
- Completed
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01921218: Completed Phase 3 study of Failing Renal Allograft, sponsored by Andrew B Adams.
NCT01921218 is a Phase 3 study of Failing Renal Allograft that has completed, run by Andrew B Adams. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921218, a Phase 3 study of Failing Renal Allograft, has completed, sponsored by Andrew B Adams.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in preventing antibody formation in patients with chronic failing kidney transplants. This study is a randomized study of first-time kidney transplant patients who have worsening kidney function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA). Patients must be eligible to get a second transplant. They must have completed or be actively undergoing evaluation for re-listing for a second transplant. Patients will be randomized to either convert to belatacept or continue on calcineurin inhibitor-based therapy.
Primary Outcome
The number of participants in each group with donor-specific antibody formation at 36 months following randomization.
Conditions Studied
Interventions
- DRUG prednisone
- DRUG Belatacept
- DRUG Mycophenolate mofetil
- DRUG Calcineurin inhibitor therapy
Study Locations (1)
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-08 |
| Est. Completion | 2019-12-12 |
| Phase | Phase 3 |
What the finished NCT01921218 record still lists
NCT01921218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Failing Renal Allograft appearing as the primary indexed condition, and to 4 interventions - of which prednisone is the first listed.
NCT01921218 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01921218 about?
NCT01921218 is a clinical study titled "Belatacept Therapy for the Failing Renal Allograft". The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in preventing antibody formation in patients with chronic failing kidney transplants. This study is a randomized study of first-time kidney transplant patients who have worsening kidney function and biopsy pro...
What is the current status of trial NCT01921218?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2013-08. Estimated completion is 2019-12-12.
What conditions does trial NCT01921218 study?
This clinical trial studies the following conditions: Failing Renal Allograft.
What interventions are being tested in trial NCT01921218?
The interventions under investigation include: prednisone (DRUG), Belatacept (DRUG), Mycophenolate mofetil (DRUG), Calcineurin inhibitor therapy (DRUG).
Who is sponsoring clinical trial NCT01921218?
This trial is sponsored by Andrew B Adams, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01921218 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01921218's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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