Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
University of Chicago
RECRUITING
Chicago
Contact Information
Primary
Piotr Witkowski, M.D. Ph.D.
pwitkowski@surgery.bs.uchicago.edu
773 702 2447
Backup
Lindsay Basto, MSN RN
Lindsay.Basto@uchospitals.edu
7737022504
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 5
Treatments
Experimental: 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
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov

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