Novel Desensitization Kidney Transplantation

Last updated: September 3, 2024
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

1/2

Condition

Kidney Transplantation

Treatment

Belatacept Injection

Clinical Study ID

NCT05345717
IRB21-0323
  • Ages 18-60
  • All Genders

Study Summary

This proposal's objective is to determine whether belatacept, in conjunction with a proteasome inhibitor can be used to safely increase the likelihood of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.

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

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Belatacept Injection
Phase: 1/2
Study Start date:
May 01, 2022
Estimated Completion Date:
December 31, 2026

Study Description

This is a pilot study to test the safety and effectiveness of the desensitization therapy with belatacept and proteasome inhibitor to increase the likelihood of of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

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