COMPLETED

Novel Desensitization Kidney Transplantation

Conditions

Kidney Transplantation End Stage Kidney Disease (ESRD)sensitized patients belatacept proteasome inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-01

Study Completion:2025-09-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05345717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Piotr Witkowski, MD PhD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Piotr Witkowski, MD PhD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01

Study Completion Date2025-09-12

Study Record Updates

Study Start Date2022-05-01

Study Completion Date2025-09-12

Terms related to this study

Keywords Provided by Researchers

kidney transplantation
sensitized patients
belatacept
proteasome inhibitor

Additional Relevant MeSH Terms

Kidney Transplantation
End Stage Kidney Disease (ESRD)