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

PHASE1CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

January 31, 2009

Study Completion Date

July 31, 2009

Conditions
End-stage Renal DiseaseRenal TransplantationKidney Transplantation
Interventions
DRUG

Conditioning Regimen

Cyclophosphamide 60 mg per kilogram (kg) of body weight per day intravenously (IV) on days -5 and -4 with respect to transplantation; humanized anti-CD2 monoclonal antibody (MEDI-507) 0.6 mg per kg on days -1, 0, and 1 (after test dose of 0.1 mg per kg on day -2); and cyclosporine A 5 mg per kg IV and thymic irradiation (700 cGy) on day -1. Hemodialysis was performed before and 14 hours after each dose of cyclophosphamide.Kidney transplantation was followed by IV infusion of donor bone marrow. Oral cyclosporine A was administered postoperatively, 8 to 12 mg per kg per day, with target trough blood levels of 250 to 350 ng per milliliter; the dose was tapered and discontinued over a period of several months. Protocol amendment that applied to participant 4 and 5: rituximab, 375 mg per square meter of body-surface area days -7 and -2; and prednisone, 2 mg per kg per day starting on the day of transplantation with tapering over the next 10 days.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00063817 - Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant | Biotech Hunter | Biotech Hunter