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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Cyclosporine; Cyclosporins; Rituximab

Criteria

Inclusion Criteria:

• End-stage renal disease (ESRD) without prior sensitization (defined as Panel Reactive Antibody [PRA] greater than 20%) within the 60 days prior to transplant as measured by cytotoxicity assays, ELISA, and flow cytometry;

• Undergoing a first or second transplant;

• Receiving a transplant from a living related donor who is ABO (blood type) compatible and haploidentical (3, 4, or 5 antigen match by serologic typing);

• Cardiac ejection fraction greater than 40%;

• Forced expiratory volume (FEV1) greater than 50%;

• Liver function tests, bilirubin, and coagulation studies less than 2 X normal;

• White blood cells greater than 2000/mm^3; abd

• Platelets greater than 100,000/mm^3

Exclusion Criteria:

• Positive donor lymphocyte cross-match;

• HIV-1 infected;

• Positive hepatitis B surface antigen (HbsAg);

• Hepatitis C virus infected;

• History of cancer;

• Prior dose-limiting radiation therapy;

• Pregnant, breastfeeding, or planning pregnancy within the time frame of the study;

• Enrolled in another investigational drug study within 30 days prior to study entry; or

• Receiving maintenance immunosuppression within 3 months before the conditioning regimen begins