Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2013-03-31
2020-06-30
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
Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
MEDI-507
T-Cell Depleting Agent
Rituximab
B-Cell Depleting Agent
Total Body Irradiation
Bone Marrow Depletion
Thymic Irradiation
Interventions
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MEDI-507
T-Cell Depleting Agent
Rituximab
B-Cell Depleting Agent
Total Body Irradiation
Bone Marrow Depletion
Thymic Irradiation
Eligibility Criteria
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Inclusion Criteria
* Candidate for a living-donor renal allograft with a one haplotype identical donor identified.
* First or second transplant with either a living donor or cadaveric transplant as the first transplant.
* Positive serologic testing for EBV indicating past exposure.
Exclusion Criteria
* Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
* Positive testing for: HIV, hepatitis B core antigen, or hepatitis C virus or positivity for hepatitis B surface antigen.
* Cardiac ejection fraction \< 40% or clinical evidence of insufficiency.
* 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 nonproliferative glomerulonephritis).
* Prior dose-limiting radiation therapy.
* Abnormal (\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
* The presence of any medical condition that the investigator deems incompatible with participation in the trial.
18 Years
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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David Sachs M.D.
Director, Transplantation Biology Research Center
Principal Investigators
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A. Benedict Cosimi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
David Sachs, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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. doi: 10.1097/MOT.0b013e3283484b2c.
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. doi: 10.1016/j.smim.2011.07.001. Epub 2011 Aug 11.
Kawai T, Cosimi AB, Spitzer TR, Tolkoff-Rubin N, Suthanthiran M, Saidman SL, Shaffer J, Preffer FI, Ding R, Sharma V, Fishman JA, Dey B, Ko DS, Hertl M, Goes NB, Wong W, Williams WW Jr, Colvin RB, Sykes M, Sachs DH. HLA-mismatched renal transplantation without maintenance immunosuppression. N Engl J Med. 2008 Jan 24;358(4):353-61. doi: 10.1056/NEJMoa071074.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2013P000822
Identifier Type: -
Identifier Source: org_study_id
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