Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Cyclophosphamide; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Rituximab; Tacrolimus

Criteria

Inclusion Criteria:

• Awaiting first or second transplant with a living donor or first transplant with a cadaveric donor

• For living-donor transplants, must have one or more HLA antigen-mismatched donors identified

• Serologic evidence of prior exposure to Epstein-Barr virus (EBV)

Exclusion Criteria:

• ABO blood group-incompatibility for a kidney graft of tissue from a donor

• Decreased circulating white blood cell count

• Positive for HIV-1, hepatitis B and C viruses

• Have had prior radiation therapy that could limit dose

• Lung capacity <50% of predicted normal

• Evidence of insufficient cardiac capacity

• Unwilling to use adequate contraception until 2 years after transplant

• Lactation or pregnancy

• Presence of antibody against the donor