Novel Desensitization Protocol for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Abatacept; Proteasome Inhibitors

Criteria

Inclusion Criteria:

• Highly sensitized patient cPRA 99-100% AND actively listed for kidney transplantation 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 months after 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 to the start of the 1st cycle.

• Actively listed for kidney transplant at the Transplant Institute at University of Chicago

Exclusion Criteria:

• Patient with significant neuropathy by the Common Terminology Criteria for Adverse Events (CTCAE) criteria within 14 days before enrollment (Grades 3-4 or Grade 2 with pain)

• Myocardial infarction within 6 months of enrollment or has Heart Failure in acute dialysis quality initiative (ADQI) ESRD classification system Class 2 non restrictive (2NR) or greater, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities

• Patient who received other investigational drugs within 14 days prior to initiation of 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 liver profile ( > 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.