Clinical trial NCT01134510 (phase 1/phase 2, status: completed)
Conditions: kidney transplantation
ICD codes: N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0
Drugs: c1 esterase inhibitor, placebos
SMILES: COCCC1=CC=C(OCC(O)CNC(C)C)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  End-stage renal disease.

          -  No known contraindications for therapy with Immune Globuillin Intravenous
             10%/Rituximab or C1 INH.

          -  Age 18-65 years at the time of screening.

          -  Panel Reactive Antibody [PRA] > 50% demonstrated on 3 consecutive samples, Patient
             highly-HLA (Human Leukocyte Antigen) sensitized and a candidate for Living
             Donor/Deceased Donor transplantation after desensitization at Cedars Sinai Medical
             Center.

          -  At transplant, patient must have Donor Specific Antibody /Cross match + non-HLA (Human
             Leukocyte Antigen) identical donor.

        Subject/Parent/Guardian must be able to understand and provide informed consent.

        Exclusion Criteria:

          -  Lactating or pregnant females.

          -  Women of child-bearing age who are not willing or able to practice Food and Drug
             Administration [FDA]-approved forms of contraception.

          -  HIV-positive subjects.

          -  Subjects who test positive for Hepatitis B Virus infection [positive Hepatitis B Virus
             surface Antigen, Hepatitis B Virus core Antigen, or Hepatitis B Virus e Antigen/DNA]
             or Hepatitis C Virus infection [positive Anti-Hepatitis C Virus (EIA) and confirmatory
             Hepatitis C Virus Recombinant ImmunoBlot Assay (RIBA)].

          -  Subjects with active Tuberculosis.

          -  Subjects with selective Immunoglobulin A deficiency, those who have known
             anti-Immunoglobulin A 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 White Blood
             Cell < .0 X 103/ml, a Hemoglobin < 8.0 g/dL, a platelet count < 100 X 103/ml, , an
             Serum Glutamic Oxaloacetic Transaminase [SGOT] > 5X upper limit of normal, and an
             Serum Glutamic Pyruvic Transaminase [SGPT] >5X upper limit of normal range.

          -  Individuals deemed unable to comply with the protocol.

          -  Subjects with active Cytomegalovirus or Epstein Barr Virus infection as defined by
             Cytomegalovirus-specific serology (Immunoglobulin G or Immunoglobulin M) and confirmed
             by quantitative Polymerase Chain Reaction 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.

          -  Use of investigational agents within 4 weeks of participation.

          -  Know allergy/sensitivity to C1 INH infusions