drugset / Trial / NCT01921218
Belatacept Therapy for the Failing Renal Allograft
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-08
- Primary completion
- 2019-12-12
- Completion
- 2019-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Comparator | Cyclosporine | Peptide | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |
Indications
No indication recorded.