Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant

Phase 1 Completed 5 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN) · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same (or nearly the same) blood cell type as the transplant recipient. An investigational medication will be given prior to and after the transplant to help protect the transplanted kidney from attack by the body's immune system.

Timeline

Start: 2003-06
Primary completion: 2009-01
Completion: 2009-07

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Siplizumab	Monoclonal antibody	0.6 mg/kg	—
Background	Cyclophosphamide	Other / unclassified	60 mg/kg	—
Background	Cyclosporine	Peptide	8 mg/kg	Intravenous
Background	Cyclosporine	Peptide	12 mg/kg	Intravenous
Background	Prednisone	Other / unclassified	2 mg/kg	—
Background	Rituximab	Monoclonal antibody	375 mg/m2	—

Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant

Summary

Timeline

Publications

Drugs

Indications