Renal Allograft Tolerance Through Mixed Chimerism

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: End Stage Renal Disease

Treatments: Radiation: Total Body Irradiation; Drug: Rituximab; Drug: MEDI-507; Radiation: Thymic Irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01780454

2013P000822

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Combined Bone Marrow and Kidney Transplantation

Experimental group

Description:

Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation

Treatment:

Radiation: Total Body Irradiation

Drug: Rituximab

Radiation: Thymic Irradiation

Drug: MEDI-507