Status:
UNKNOWN
Inducing Graft Tolerance in HLA Haplotype Matched Related and 3 Ag Matched Unrelated Living Donor Kidney Transplantation
Lead Sponsor:
Samuel Strober
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
Immune Tolerance
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
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 match...
Detailed Description
The objectives of this study are to determine whether patients undergoing kidney transplants for end stage renal disease (ESRD) can be taken off immune suppression drugs given to prevent kidney reject...
Eligibility Criteria
Inclusion
- All consenting adults (18 years of age) living donor renal transplant recipients at Stanford University Medical Center who have a one haplotype match donor.
- Patients who agree to participate in the study and sign an Informed Consent.
- Patients who have no known contraindication to administration of rabbit ATG or radiation.
- Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 24 months posttranplant.
Exclusion
- Previous treatment with rabbit ATG or known allergy to rabbit proteins.
- History of malignancy with the exception of non-melanoma skin malignancies.
- Pregnant women or nursing mothers.
- Serological evidence of HIV, Hepatitis B or Hepatitis C infection.
- Seronegative for Epstein-Barr virus , if donor is seropositive.
- Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3)
- Panel Reactive antibody greater then 20% or demonstration of donor specific antibody (DSA).
- Prior organ transplantation.
- High risk of primary kidney disease recurrence (i.e. primary FSGS).
Key Trial Info
Start Date :
February 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 14 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03292445
Start Date
February 14 2017
End Date
February 14 2024
Last Update
July 17 2020
Active Locations (2)
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1
Stanford University Medical Center
Palo Alto, California, United States, 94304
2
University of Wisconsin
Madison, Wisconsin, United States, 53792-1690