Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)
NCT ID: NCT02314403
Last Updated: 2021-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2015-02-28
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combined Bone Marrow and Kidney Transplantation
Recipients will receive a conditioning regimen that starts with Rituximab on day -7 (and days -2, 5, 12), Whole Body Irradiation 1.5 Gy x2 on study days -6 and -5, followed by ATG on Days -2, -1, 0. Belatacept 10mg/kg on Days 0, 3, 10, 17, 24, 38, 52. Thymic irradiation (7 Gy) will be given on study day -1, and combined renal and bone marrow transplant will be done on study day 0. Prednisone will be started at 2 mg/kg on day 4 and tapered off by day 20. Tacrolimus will be administered on study days -1 through 60, and then tapered if weaning criteria are met.
Belatacept
A selective T-cell (lymphocyte) costimulation blocker
ATG
A T-Cell Depleting Agent
Rituximab
B-Cell Depleting Agent
Total Body Irradiation
Thymic Irradiation
Combined Bone Marrow/Kidney Transplantation
Interventions
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Belatacept
A selective T-cell (lymphocyte) costimulation blocker
ATG
A T-Cell Depleting Agent
Rituximab
B-Cell Depleting Agent
Total Body Irradiation
Thymic Irradiation
Combined Bone Marrow/Kidney Transplantation
Eligibility Criteria
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Inclusion Criteria
* Candidate for a living-donor renal allograft from an HLA mismatched donor
* First or second transplant with either a living donor or cadaveric transplant as the first transplant.
* Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation.
* Ability to understand and provide informed consent.
* Serologic evidence of prior exposure to EBV.
Exclusion Criteria
* Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
* Leukopenia or thrombocytopenia.
* Positive for HIV-1, hepatitis B core antigen, or hepatitis C virus; or positivity for hepatitis B surface antigen.
* Cardiac ejection fraction \< 40% or clinical evidence of insufficiency.
* Forced expiratory volume FEV1 \< 50% of predicted.
* Lactation or pregnancy.
* History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type I or II membranoprolifertive glomerulonephritis).
* Prior dose-limiting radiation therapy.
* Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen.
* Enrollment in other investigational drug studies within 30 days prior to enrollment.
* Abnormal (\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
* Allergy or sensitivity to any component of belatacept, ATG, tacrolimus, or rituximab.
* Maintenance immunosuppression within 3 months prior to conditioning other than physiological doses of steroids, defined as ≤ 50 mg of hydrocortisone or dose equivalent.
* The presence of any medical condition that the investigator deems incompatible with participation in the trial.
18 Years
60 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Tatsuo Kawai, MD, PhD
Associate Professor of Surgery, Harvard Medical School
Principal Investigators
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Tatsuo Kawai, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Related Links
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Kawai T, Cosimi AB, Sachs DH. Preclinical and clinical studies on the induction of renal allograft tolerance through transient mixed chimerism. Curr Opin Organ Transplant. 2011 Aug;16(4):366-71.
Sachs DH, Sykes M, Kawai T, Cosimi AB. Immuno-intervention for the induction of transplantation tolerance through mixed chimerism. Semin Immunol. 2011 Jun;23(3):165-73.
Kawai T, (et.al.) HLA-mismatched renal transplantation without maintenance immunosuppression. N Engl J Med. 2008 Jan 24;358(4):353-61.
Other Identifiers
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MGH Tolerance Trial
Identifier Type: -
Identifier Source: org_study_id