Tolerance by Engaging Antigen During Cellular Homeostasis

Exclusion Criteria

• •Recipient:
• •History of any immunodeficiency syndrome (including Human Immunodeficiency Virus-1 (HIV-1) and HIV-2);
• •Positive anti-Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR), anti-Hepatitis C Virus (HBV) PCR, or HBV surface antigen;
• •History of malignancy within 5 years of enrollment or any history of hematogenous malignancy or lymphoma; --Exception: Participants with curatively treated non-melanomatous skin cancer or curatively treated cervical carcinoma in situ may be enrolled.
• •Underlying renal disease with high likelihood of recurrence, including but not limited to:
• •* primary focal segmental glomerulosclerosis (FSGS),
• •* Type I or II membranoproliferative glomerulonephritis (MPGN),
• •* hemolytic-uremic syndrome and
• •* thrombotic thrombocytopenic purpura (HUS/TTP) syndrome. ---Subject(s) with end-stage renal disease (ESRD) of unknown etiology and/or has no histologically confirmed diagnosis, may be enrolled into the study as long as there are no clinical signs or symptoms consistent with excluded clinical diagnoses.
• •History of active M. tuberculosis:
• •--Participants with a history of latent M. tuberculosis (LTB) as defined by positive testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON®-Gold TB or T-SPOT-TB assay must:
• •* have completed treatment for LTB and
• •* have a negative chest x-ray. ----All participants will undergo IGRA testing for M tuberculosis within 3 months prior to transplant.
• •Current or historical evidence of donor-specific antibody;
• •Immunosuppressive drug therapy within one year prior to enrollment.
• •May not be taking or have taken prednisone, cyclosporine A, tacrolimus, azathioprine, Mycophenolate Mofetil (MMF), cyclophosphamide, methotrexate, infliximab, etanercept, or other agents which have a primary therapeutic effect of immunosuppression in the year prior to transplantation.
• •May not have taken depletional anti-lymphocyte agents at any time.
• •---Exceptions:
• •* Short (≤ 30 days) courses of topical or inhaled steroids are permitted, as are
• •* Short oral or parental pulses for a documented hypersensitivity reaction.
• •Active autoimmune disease requiring ongoing immunosuppressive therapy or other conditions in which there is an anticipated need for immunosuppressive maintenance therapy;
• •Uncompensated congestive heart failure, pulmonary edema, or symptomatic pulmonary hypertension;
• •Active severe infection within a month of the screening visit;
• •Use of an investigational drug within 30 days of the screening visit;
• •Presence of any medical condition that the investigator deems incompatible with trial participation; or
• •Inability or unwillingness to comply with protocol monitoring and therapy.
• •Donor:
• •History of blood donation to the recipient;
• •Evidence of prior Cytomegalovirus (CMV) infection if the recipient is CMV negative;
• •History of HIV-1/HIV-2 infection;
• •Positive HCV PCR, HBV PCR or HBV surface antigen;or
• •Presence of any medical condition that the investigator deems incompatible with trial participation.