Renal Allograft Tolerance Through Mixed Chimerism
This trial is active, not recruiting.
|Condition||end stage renal disease|
|Treatments||medi-507, rituximab, total body irradiation, thymic irradiation|
|Phase||phase 1/phase 2|
|Sponsor||Massachusetts General Hospital|
|Start date||March 2013|
|End date||October 2018|
|Trial size||2 participants|
|Trial identifier||NCT01780454, 2013P000822|
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system
|Intervention model||single group assignment|
Successful withdrawal of immunosuppressive therapy
time frame: 5 years
Incidence of Engraftment Syndrome
time frame: 5 Years
Male or female participants from 18 years up to 65 years old.
Key Inclusion Criteria: - Male or female 18-60 years of age - 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. Key Exclusion Criteria: - ABO blood group-incompatible renal allograft. - 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.
|Official title||Renal Allograft Tolerance Through Mixed Chimerism|
|Principal investigator||A. Benedict Cosimi, M.D.|
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