drugset / Trial / NCT00859131
Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists
RandomizedParallel-groupOpen-label
Summary
The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).
Timeline
- Start
- 2009-03
- Primary completion
- 2012-07
- Completion
- 2014-07
Publications
- Palanisamy AP, Al Manasra AR, Pilch NA, Dowden JE, Nadig SN, McGillicuddy JW, Baliga PK, Chavin KD, Taber DJ. Induction therapy: clinical and quality of life outcomes in aged renal transplant recipients. Clin Transplant. 2015 Mar;29(3):222-6. doi: 10.1111/ctr.12507. Epub 2015 Jan 27.
- Pilch NA, Taber DJ, Moussa O, Thomas B, Denmark S, Meadows HB, McGillicuddy JW, Srinivas TR, Baliga PK, Chavin KD. Prospective randomized controlled trial of rabbit antithymocyte globulin compared with IL-2 receptor antagonist induction therapy in kidney transplantation. Ann Surg. 2014 May;259(5):888-93. doi: 10.1097/SLA.0000000000000496.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Daclizumab | Monoclonal antibody | 1 mg/kg | — |
| Comparator | rabbit anti-thymocyte globulin | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |