drugset / Trial / NCT00275509
Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.
Timeline
- Start
- 2007-01
- Primary completion
- 2010-06
- Completion
- 2010-06
Publications
- Background Haas M, Sis B, Racusen LC, Solez K, Glotz D, Colvin RB, Castro MC, David DS, David-Neto E, Bagnasco SM, Cendales LC, Cornell LD, Demetris AJ, Drachenberg CB, Farver CF, Farris AB 3rd, Gibson IW, Kraus E, Liapis H, Loupy A, Nickeleit V, Randhawa P, Rodriguez ER, Rush D, Smith RN, Tan CD, Wallace WD, Mengel M; Banff meeting report writing committee. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272-83. doi: 10.1111/ajt.12590.
- Background Solez K, Colvin RB, Racusen LC, Haas M, Sis B, Mengel M, Halloran PF, Baldwin W, Banfi G, Collins AB, Cosio F, David DS, Drachenberg C, Einecke G, Fogo AB, Gibson IW, Glotz D, Iskandar SS, Kraus E, Lerut E, Mannon RB, Mihatsch M, Nankivell BJ, Nickeleit V, Papadimitriou JC, Randhawa P, Regele H, Renaudin K, Roberts I, Seron D, Smith RN, Valente M. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant. 2008 Apr;8(4):753-60. doi: 10.1111/j.1600-6143.2008.02159.x. Epub 2008 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclizumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | — |
| Background | Cytogam | Protein / enzyme biologic | 100 mg/kg | — |
| Background | Dexamethasone | Small molecule | 25 mg | — |
| Background | Mycophenolate Mofetil | Small molecule | 2 g | — |
| Background | Prednisone | Other / unclassified | 5 mg | — |
| Background | Tacrolimus | Small molecule | — | — |