Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.
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|ClinicalTrials.gov Identifier: NCT01165762|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2010
Last Update Posted : July 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|ESRD||Drug: Immune Tolerance||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion in HLA Haplotype Match Living Donor Kidney Transplantation|
|Actual Study Start Date :||July 14, 2010|
|Estimated Primary Completion Date :||June 14, 2023|
|Estimated Study Completion Date :||June 14, 2025|
Experimental: Immune Tolerance, Kidney transplantation
Induction of immune tolerance in Haplotype matched living donor kidney transplantation.
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
- Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival. [ Time Frame: 5 years and indefinitely if possible ]Subjects on study will have tapering of the immunosuppressive medication and withdrawal of the immunosuppressive medication if withdrawal criteria are met.
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- All consenting adults who are 18 to 60 years, living donor transplant candidates and have a haplotype related living donor or > 2 HLA antigen matched, unrelated, living donor (including at least one HLA-DR antigen match plus at least one antigen match of either HLA-A or HLA-B).
- 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 post-transplant.
- ABO compatible.
- 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 80% or demonstration of donor specific antibody (DSA).
- Prior organ transplantation.
- High risk of primary kidney disease recurrence (e.g atypical HUS). However, patients with primary FSGS will not be excluded.
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
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792-1690|
|Principal Investigator:||Stephan Busque, MD,MS||Stanford University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Everett Meyer, Associate Professor of Medicine, Stanford University|
|Other Study ID Numbers:||
P01HL075462 ( U.S. NIH Grant/Contract )
|First Posted:||July 20, 2010 Key Record Dates|
|Last Update Posted:||July 6, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|