Combined Blood Stem Cell and Human Leukocyte Antigen (HLA) Haplotype Match Living Donor Kidney Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2010 by Stanford University
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01165762
First received: July 13, 2010
Last updated: July 19, 2010
Last verified: July 2010
  Purpose

The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone marrow Transplantation are enrolling patients into a research study to determine if donor stem cells given after a living related one Haplotype match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.


Condition Intervention
Kidney Transplantation
Procedure: Total Lymphoid Radiation with Donor hematopoietic stem Cell and Kidney Transplant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion in HLA Haplotype Match Living Donor Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival. [ Time Frame: 5 years and indefinitely if possible ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: July 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The goal of this study is for the recipients of a living related kidney transplant of one HLA haplotype to be withdrawn of immunosuppressive medication and become "tolerant "to their kidney graft. The recipient will receive a conditioning regimen composed of low dose radiation to the lymphoid tissue (total lymphoid irradiation, TLI) and anti-thymocyte globulin (ATG) at the time of transplant. They will then be infused with purified "stem cell" and T-cell from their kidney donors 2 weeks after the transplant to try to achieve mixed chimerism of their white blood cells with the donor (the recipient would have a mixture some of the with blood cells of the donor and theirs in their blood). The kidney donor has to provide peripheral stem cell 6-8 weeks before kidney donation. It is an outpatient procedure done using peripheral veins after treatment with G-CSF (filgrastim).Immunosuppressive medication will be decreased gradually and possibly stopped by the end of the first year after the transplantation if the recipient meets withdrawing criteria (persistence of mixed chimerism more than 180 days, no episode of rejection and no rejection on surveillance kidney biopsy). Potential candidates need to be approved for kidney transplant and available for close follow-up at Stanford University Medical Center.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All consenting adult (> 21 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 posttransplant.
  5. The donor and the recipient must have an identical blood group.

Exclusion Criteria:

  1. Previous treatment with rabbit 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 or Hepatitis C infection.
  5. Seronegative for CMV, if donor is seropositive.
  6. Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
  7. PRA greater than 20% or demonstration of donor specific antibody (DSA)
  8. Prior organ transplantation
  9. High risk of primary kidney disease recurrence (i.e.FSGS)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165762

Contacts
Contact: Asha Shori, CCRP (650) 736-0245 ashas@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Asha Shori, CCRP    650-736-0245    ashas@stanford.edu   
Contact: Stephan Busque, MD    (650) 723-5454    sbusque@stanford.edu   
Study Director: John D Scandling         
Sub-Investigator: Judith Anne Shizuru         
Sub-Investigator: Dr. Marc L. Melcher         
Sub-Investigator: Richard T. Hoppe         
Sub-Investigator: Robert Lowsky         
Sub-Investigator: Julie M. Yabu         
Study Chair: Samuel Md Strober         
Principal Investigator: Stephan Busque         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stephan Busque Stanford University
  More Information

Publications:
Responsible Party: Stephan Busque, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01165762     History of Changes
Other Study ID Numbers: SU-06232010-6408, 18731
Study First Received: July 13, 2010
Last Updated: July 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 14, 2014