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Trial record 1 of 1 for:    NCT05345717
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Novel Desensitization Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT05345717
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation End Stage Kidney Disease (ESRD) Drug: Belatacept Injection Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A pilot study on 5 subjects
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Belatacept Injection
Patient will initiate belatacept therapy and will received 2 cycles of proteasome inhibitor therapy
Other Name: proteasome inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA). [ Time Frame: 1 year ]
    The likelihood of finding a suitable donor will calculated base on calculated Panel of Reactive Antibodies measured 1month after the therapy


Secondary Outcome Measures :
  1. Strong Human Leukocyte Antigen (HLA) antibodies with mean fluorescence intensity (MFI) reduced by more than 50% [ Time Frame: 1 year ]
    A number of strong HLA antibodies with MFI reduced by more than 50% will be counted

  2. Time to transplant [ Time Frame: 1 year ]
    Time from the beginning of the implementation of the therapy to kidney transplantation will be measured

  3. Episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR) [ Time Frame: 1 year ]
    Number of episodes of AMR and ACR after kidney transplantation will be counted

  4. Death [ Time Frame: 1 year ]
    The incidence of episodes of patient death will be calculated

  5. Serious infection requiring inpatient intravenous therapies [ Time Frame: 1 year ]
    Incidence rate of the episodes of serious infection requiring inpatient intravenous therapies will be calculated during the study

  6. Post-transplant lymphoproliferative disorder [ Time Frame: 1 year ]
    The incidence rate of the episodes of post-transplant lymphoproliferative disorder will be calculated


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05345717


Contacts
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Contact: Piotr Witkowski, M.D. Ph.D. 773 702 2447 pwitkowski@surgery.bs.uchicago.edu
Contact: Lindsay Basto, MSN RN 7737022504 Lindsay.Basto@uchospitals.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Piotr Witkowski, MD PhD    773-702-2447    pwitkowski@surgery.bs.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Piotr Witkowski, MD PhD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT05345717    
Other Study ID Numbers: IRB21-0323
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
kidney transplantation
sensitized patients
belatacept
proteasome inhibitor
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Abatacept
Proteasome Inhibitors
Immune Checkpoint Inhibitors
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Protease Inhibitors
Enzyme Inhibitors