Inducing Graft Tolerance in HLA Haplotype Matched Related and 3 Ag Matched Unrelated Living Donor Kidney Transplantation

Trial ID or NCT#

NCT03292445

Status

recruiting iconRECRUITING

Purpose

This research study is to determine if donor blood stem cells given after living, related, HLA antigen (Ag) haplotype match or living, unrelated donor kidney transplantation. Minimal HLA antigen matching will include matching of 2 HLA antigens that can be either HLA A, B, and /or DR. This research will change the immune system such that immunosuppressive drugs can be completely withdrawn or reduced to minimal dose without kidney rejection.

Official Title

Induction of Immune Tolerance by Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T Cell Transfusion in HLA Haplotype Matched Related and 3 Antigen HLA Matched Unrelated Living Donor Kidney Transplantation

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. All consenting adults (18 years of age) living donor renal transplant recipients at Stanford University Medical Center who have a one haplotype match donor. 2. Patients who agree to participate in the study and sign an Informed Consent. 3. Patients who have no known contraindication to administration of rabbit ATG or radiation. 4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 24 months posttranplant.
Exclusion Criteria:
  1. 1. Previous treatment with rabbit ATG or known allergy to rabbit proteins. 2. History of malignancy with the exception of non-melanoma skin malignancies. 3. Pregnant women or nursing mothers. 4. Serological evidence of HIV, Hepatitis B or Hepatitis C infection. 5. Seronegative for Epstein-Barr virus , if donor is seropositive. 6. Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3) 7. Panel Reactive antibody greater then 20% or demonstration of donor specific antibody (DSA). 8. Prior organ transplantation. 9. High risk of primary kidney disease recurrence (i.e. primary FSGS).

Investigator(s)

Stephan Busque
Stephan Busque
Transplant surgeon, Kidney transplant surgeon, Pancreas transplant surgeon
Professor of Surgery (Abdominal Transplantation)
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Marc L. Melcher
Marc L. Melcher
Transplant surgeon, Liver transplant surgeon, Kidney transplant surgeon, Hepatobiliary surgeon, Dialysis access surgeon
Professor of Surgery (Abdominal Transplantation)
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Judith Shizuru
Judith Shizuru
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist, Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Asha Shori, CCRP
650-736-0245