10
Participants
Start Date
August 31, 2001
Primary Completion Date
July 31, 2014
Study Completion Date
July 31, 2014
Cyclophosphamide, anti-thymocyte globulin
"Cyclophosphamide 60 mg/kg IV on Day -5, -4 Anti-thymocyte globulin 20 mg/kg IV on Day -1, Day +1, +3, +5~Cyclosporine starting on Day -1 at 5 mg/kg daily I.V. and reduced to 3 mg/kg on Day +4, and adjusted to provide a trough whole blood concentration of 250-400 ng/mL. The route of administration will be changed to oral as soon as the patient is able to tolerate oral medications"
Kidney transplant
On Day 0 the renal transplant is performed according to standard surgical techniques, preferably using an iliac fossa, extraperitoneal approach
Thymic irradiation
Thymic irradiation 7 Gy on Day -1
Bone marrow transplant from a related donor
• Donor bone marrow (\> 2 x 108 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure at the medical center. A total of 15,000 Units of heparin is mixed with the marrow, which is infused at a rate of 300-500 cc/hr. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Protamine, 25 mg, is administered I.V. after completion of the first half of the bone marrow infusion. If a partial thromboplastin time measured after completion of the marrow infusion is \> 60 seconds, the protamine treatment shall be repeated
Massachusetts General Hospital, Boston
Massachusetts General Hospital
OTHER