Phase
Condition
Kidney Transplantation
Treatment
Belatacept Injection
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Highly sensitized patient cPRA 99-100% AND actively listed for kidneytransplantation at the kidney transplantation Program at University fo Chicago
Ebstein Barr Virus (EBV) Immunoglobulins (IgG) seropositive
No active systemic infection
No allergy to proteasome inhibitors (Bortezomib), or to belatacept
No known malignancy in the previous 2 years except for non-melanomatous skin cancer
Female who agrees to practice 2 effective methods of contraception through 3 monthsafter the last dose of Bortezomib
Patient vaccinated against hepatitis B virus with positive level of HBsAb
Patients fully vaccinated against Coronavirus Disease 2019 at least 2 weeks prior tothe start of the 1st cycle.
Actively listed for kidney transplant at the Transplant Institute at University ofChicago
Exclusion
Exclusion Criteria:
Patient with significant neuropathy by the Common Terminology Criteria for AdverseEvents (CTCAE) criteria within 14 days before enrollment (Grades 3-4 or Grade 2 withpain)
Myocardial infarction within 6 months of enrollment or has Heart Failure in acutedialysis quality initiative (ADQI) ESRD classification system Class 2 nonrestrictive (2NR) or greater, uncontrolled angina, severe uncontrolled ventriculararrhythmias, or ECG evidence of acute ischemia or active conduction systemabnormalities
Patient who received other investigational drugs within 14 days prior to initiationof study treatment
Receipt of a live vaccine within 4 weeks prior to initiation of study treatment
Evidence of severe liver disease by history or physical exam or with abnormal liverprofile ( > 1.5 times upper limit of normal within 30 days of consent)
Female who is breast feeding or pregnant
Untreated latent tuberculosis
History of Post Transplant Lymphoproliferative Disease (PTLD)
Patient still carrying previous kidney transplant.
Study Design
Study Description
Connect with a study center
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
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