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Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure, Chronic; Renal Insufficiency

Intervention: Belatacept (Drug); ATG (Drug); Rituximab (Drug); Total Body Irradiation (Radiation); Thymic Irradiation (Radiation); Combined Bone Marrow/Kidney Transplantation (Procedure)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Tatsuo Kawai, MD PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Kerry Crisalli, RN BSN CCRC, Phone: 617-643-4087, Email: kcrisalli@mgh.harvard.edu

Summary

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

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Successful withdrawal of immunosuppression

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female 18-60 years of age

- 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:

- 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)

- 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.

Locations and Contacts

Kerry Crisalli, RN BSN CCRC, Phone: 617-643-4087, Email: kcrisalli@mgh.harvard.edu

Additional Information

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.

Kawai T, (et. al.) Long-Term Results in Recipients of Combined HLA-Mismatched Kidney and Bone Marrow Transplantation Without Maintenance Immunosuppression

Starting date: February 2015
Last updated: December 8, 2014

Page last updated: August 23, 2015

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