drugset / Trial / NCT00801632
Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection
Phase 2
Completed
5 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
NaSingle-groupOpen-labelTreatment
Summary
In small initial studies, combined kidney and bone marrow transplants from the same donor have permitted some individuals to stop taking anti-rejection medicines without rejecting their transplant. This clinical trial will study this method in a greater number of people to determine if it is indeed effective and safe.
Timeline
- Start
- 2008-12
- Primary completion
- 2014-04
- Completion
- 2014-11
Publications
- Background Kawai T, Cosimi AB, Spitzer TR, Tolkoff-Rubin N, Suthanthiran M, Saidman SL, Shaffer J, Preffer FI, Ding R, Sharma V, Fishman JA, Dey B, Ko DS, Hertl M, Goes NB, Wong W, Williams WW Jr, Colvin RB, Sykes M, Sachs DH. HLA-mismatched renal transplantation without maintenance immunosuppression. N Engl J Med. 2008 Jan 24;358(4):353-61. doi: 10.1056/NEJMoa071074.
- Results Kawai T, Sachs DH, Sykes M, Cosimi AB; Immune Tolerance Network. HLA-mismatched renal transplantation without maintenance immunosuppression. N Engl J Med. 2013 May 9;368(19):1850-2. doi: 10.1056/NEJMc1213779. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Background | Methylprednisolone | Other / unclassified | 500 mg | — |
| Background | Prednisone | Other / unclassified | 2 mg/kg | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Siplizumab | Monoclonal antibody | 0.6 mg/kg | — |
| Background | Tacrolimus | Small molecule | 0.05 mg/kg | Intravenous |