A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test

Exclusion Criteria

• •Previous treatment with IdeS
• •Previous high dose IVIg treatment (2 g/kg BW) within 28 days prior to IdeS treatment
• •Lactating or pregnant females
• •Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception
• •HIV-positive patients
• •Patients with clinical signs of HBV or HCV infection
• •Patients with active tuberculosis
• •A significantly abnormal general serum screening lab result according to the investigator's judgement. Hgb cannot be \< 6.0 g/dL
• •Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
• •Individuals deemed unable to comply with the protocol
• •Patients with clinical signs of CMV or EBV infection
• •Patients with a history of major thrombotic events, patients with active peripheral vascular disease or patients with proven hypercoagulable conditions
• •Patients should not have received investigational drugs within 4 half-lives (or similar)
• •Known allergy/sensitivity to IdeS infusions
• •Patients who have a live donor and test positive for ImmunoCap anti-IdeS IgE