A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: IdeS; Kidney transplantation
Intervention description: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.; Performed following IdeS treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients
      who are on the waiting list for kidney transplant and have previously undergone
      desensitization unsuccessfully or in whom effective desensitization will be highly unlikely.
      At study entry, the patients will have an available deceased or live donor with a positive
      crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific
      Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients on the kidney transplant waitlist who have previously undergone
             desensitization unsuccessfully or in whom effective desensitization will be highly
             unlikely. The breadth and strength of sensitization will predict an extremely low
             likelihood of successful desensitization or kidney paired donation.

          -  Patients with a live or deceased donor 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