Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01165762 |
Recruitment Status
:
Recruiting
First Posted
: July 20, 2010
Last Update Posted
: December 7, 2016
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Condition or disease | Intervention/treatment | Phase |
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ESRD | Drug: Immune Tolerance | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | July 2010 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Immune Tolerance, Kidney transplantation
Induction of immune tolerance in Haplotype matched living donor kidney transplantation.
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Drug: Immune Tolerance
Immune tolerance Kidney and hematopoietic cell transplantation with a conditioning regimen of total lymphoid irradiation and antithymocyte globulin followed by immunosuppressive drugs for 18 months. Immunosuppressive drugs are stopped if stable chimerism is achieved and there is no rejection of the transplant kidney. The IDE used in this study is the column used for hematopoietic cell sorting. Other Name: Kidney transplantation
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- Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival. [ Time Frame: 5 years and indefinitely if possible ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All consenting adult (> 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 posttransplant.
- ABO compatible.
Exclusion Criteria:
- Previous treatment with rabbit ATG or a 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 than 20% or demonstration of donor specific antibody (DSA)
- Prior organ transplantation
- High risk of primary kidney disease recurrence (i.e.FSGS)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165762
Contact: Asha Shori, CCRP | (650) 736-0245 | ashas@stanford.edu |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Asha Shori, CCRP 650-736-0245 ashas@stanford.edu | |
Principal Investigator: 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 | |
Principal Investigator: Samuel Md Strober | |
Principal Investigator: Stephan Busque |
Principal Investigator: | Stephan Busque | Stanford University |
Publications:
Responsible Party: | Stephan Busque, Professor of Surgery, Abdominal Transplantation, Stanford University Medical Center, Stanford University |
ClinicalTrials.gov Identifier: | NCT01165762 History of Changes |
Other Study ID Numbers: |
SU-06232010-6408 P01HL075462 ( U.S. NIH Grant/Contract ) |
First Posted: | July 20, 2010 Key Record Dates |
Last Update Posted: | December 7, 2016 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |