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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 is a Phase 3 study of Failing Renal Allograft that has completed, run by Andrew B Adams. The registered enrollment target is 13 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01921218
The ClinicalTrials.gov registry entry for NCT01921218 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Andrew B Adams, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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