Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.
Trial ID or NCT#
NCT03591302
Status
NOT RECRUITING
Purpose
The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.
Official Title
Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation .
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection.2. Patients who agree to participate in the study and sign an Informed Consent3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.5. Patients who have no known contraindication to the administration of rabbit ATG or radiation6. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.
Exclusion Criteria:
- 1. Known allergy to ATG or a 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 (HepBsAg+) or Hepatitis C infection.5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (platelet count \< 100,000/mm3)6. Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease.7. Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than 1.
Investigator(s)
John Scandling
Kidney transplant specialist,
Tolerance induction protocol specialist
Professor of Medicine (Nephrology) at the Stanford University Medical Center, Emeritus
Stephan Busque
Transplant surgeon,
Kidney transplant surgeon,
Pancreas transplant surgeon
Professor of Surgery (Abdominal Transplantation)
Everett Meyer
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Hematologist,
Transplant immunologist,
Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), of Pediatrics (Stem Cell Transplantation) and, by courtesy, of Surgery (Abdominal Transplantation)
Khoa Thomas Pham
Transplant surgeon,
Kidney transplant surgeon,
Liver transplant surgeon,
General surgeon
Clinical Associate Professor, Surgery - Abdominal Transplantation
Colin Lenihan
Robert Lowsky
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
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)
View on ClinicalTrials.gov
