Novel Desensitization Kidney Transplantation

NCT ID: NCT05345717

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-09-12

Brief 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.

Detailed 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.

Conditions

Kidney Transplantation; End Stage Kidney Disease (ESRD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients treated with belatacept and proteasome inhibitor

Highly sensitized patients will be treated with belatacept and proteasome inhibitor and monitored for decreasing calculated Panel of Reactive Antibodies (cPRA) and suitable kidney donor base don negative crossmatch

Group Type: EXPERIMENTAL

Belatacept Injection

Intervention Type: DRUG

Patient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy

Interventions

Belatacept Injection

Patient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy

Intervention Type: DRUG

Other Intervention Names

proteasome inhibitor

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Witkowski, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB21-0323

Identifier Type: -

Identifier Source: org_study_id