Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation

Inclusion Criteria

• End-stage renal disease awaiting transplantation on the UNOS list.
• No known contraindications for therapy with IVIG10%/Rituximab, plasmapheresis (PLEX) or IdeS®.
• Age 18-70 years at the time of screening.
• Calculated PRA (CPRA)> 50% demonstrated on 3 consecutive samples, Patient highly-HLA sensitized and a candidate for DD transplantation after desensitization at CSMC.
• At transplant, patient must have donor-specific antibody/ crossmatch positive (DSA/CMX+) non-HLA identical donor.
• Pre-transplant vaccination with Streptococcus pneumoniae and Nisseria meningitides
• Subject/Parent/Guardian must be able to understand and provide informed consent.

Exclusion Criteria

• Positivity for anti-IdeS IgE
• Use of IVIG 4 weeks prior to planned IdeS® administration
• Recipients of Extended Criteria Donors (ECD) or Living Donors (LD)
• Lactating or pregnant females.
• Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception.
• HIV-positive subjects.
• Subjects who test positive for HBV infection [positive HBVsAg, HBVcAb, or HBVeAg/DNA] or HCV infection [positive Anti-HCV (EIA) and confirmatory HCV RIBA].
• Subjects with active TB.
• Subjects with selective IgA deficiency, those who have known anti-IgA antibodies, and those with a history of anaphylaxis or severe systemic responses to any part of the clinical trial material.
• Subjects who have received or for whom multiple organ transplants are planned.
• Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit (including but not limited to any of the following:
• Adenovirus [Adenovirus vaccine live oral type 7]
• Varicella [Varivax]
• Hepatitis A [VAQTA]
• Rotavirus [Rotashield]
• Yellow fever [Y-F-Vax]
• Measles and mumps [Measles and mumps virus vaccine live]
• Measles, mumps, and rubella vaccine [M-M-R-II]
• Sabin oral polio vaccine
• Rabies vaccines [IMOVAX Rabies I.D., RabAvert])
• A significantly abnormal general serum screening lab result defined as a WBC 3X upper limit .
• Individuals deemed unable to comply with the protocol.
• Subjects with active CMV or EBV infection as defined by CMV-specific serology (IgG or IgM) and confirmed by quantitative PCR with or without a compatible illness.
• Subjects with a known history of previous myocardial infarction within one year of screening.
• Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
• Subjects with Protein C and Protein S deficiency
• Use of investigational agents within 4 weeks of participation.
• Known allergy/sensitivity to IdeS® infusions