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
Target CD20
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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
T-Cell Depleting Agent
B-Cell Depleting Agent
total body irradiation
Bone Marrow Depletion
thymic irradiation

Primary Outcomes

Successful withdrawal of immunosuppressive therapy
time frame: 5 years

Secondary Outcomes

Incidence of Engraftment Syndrome
time frame: 5 Years

Eligibility Criteria

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.

Additional Information

Official title Renal Allograft Tolerance Through Mixed Chimerism
Principal investigator A. Benedict Cosimi, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.