Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046549
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Viela Bio

Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased, living unrelated or human leukocyte antigen (HLA) non-identical living related donor.

Condition or disease Intervention/treatment Phase
Allografts Rejection; Transplant, Kidney Transplant Rejection Kidney Transplantation Drug: Belatacept Drug: VIB4920 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2a Single-arm, Prospective, Open-label Pilot Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : June 17, 2022
Estimated Study Completion Date : February 24, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arm Intervention/treatment
Experimental: Belatacept+VIB4920
Participants will be admitted to the transplant center for the administration of VIB4920 and belatacept and will be discharged on Day 3/4 at the discretion of the investigator. Participants will return to the study center to receive study drugs (VIB4920 and /or belatacept) weekly for 2 visits, then every 2 weeks for 5 visits, and then monthly for 9 visits for safety monitoring.
Drug: Belatacept
Belatacept Dose 1 will be administered intravenously on post-op Day 1, repeated on post-op Day 3 or 4, and at the end of Weeks 2, 4, 8 and 12; then Dose 2 every four weeks from Week 16 to Week 48.

Drug: VIB4920
VIB4920 Dose 1 will be administered intravenously on post-op Days 1, and 14, and at the end of Weeks 4, 6, 8 and 10; then will continue every four weeks from Week 12 to Week 48.




Primary Outcome Measures :
  1. Number of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Incidence of Treated Biopsy-proven Acute Rejection (tBPAR), graft loss, death or loss to follow-up (LTFU) [ Time Frame: Week 12, 24, 48 ]
  2. Incidence of antibody-mediated rejection [ Time Frame: Week 12, 24, 48 ]
  3. Incidence of Treated Biopsy-proven Acute Rejection (tBPAR) [ Time Frame: Week 12, 24, 48 ]
  4. Incidence of Biopsy Proven Acute Rejection (BPAR) [ Time Frame: Week 12, 24, 48 ]
  5. Incidence of treated acute rejections [ Time Frame: Week 12, 24, 48 ]
  6. Proportion of Participants with De novo donor-specific antibodies (dnDSA) [ Time Frame: Week 12, 24, 48 ]
    Serum samples will be collected at the timepoints specified for de novo donor-specific antibodies (dnDSA) using solid phase (bead-based) assays.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recipients of a first renal transplant from standard criteria deceased, living unrelated or HLA non-identical living related donor.
  • Recipients who are at low immunologic risk:

    1. No donor specific antibodies (DSA), and
    2. Negative cross-match testing.
  • Recipients with up to date vaccination as per local immunization schedules.
  • Male and female participants who agree to follow protocol defined contraceptive methods.

Exclusion Criteria:

  • Participants receiving an allograft from an ABO-incompatible donor.
  • Participants treated with systemic immunosuppressive drug therapy for more than a total of 2 weeks within 24 weeks prior to informed consent form signature.
  • Participants who have undergone lymphodepleting therapy.
  • Participants with medical history of confirmed venous thromboembolism, arterial thrombosis, coagulopathy or known platelet disorders.
  • Participants with risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status.
  • Participants requiring treatment with antithrombotic drugs (clopidogrel, prasugrel, warfarin, others).
  • Participants requiring long-term systemic anticoagulation after transplantation, which would interfere with obtaining biopsies.
  • Participants with any contraindication to kidney biopsy.
  • Cytomegalovirus (CMV)-seronegative recipients of a CMV-seropositive donor kidney, or unknown CMV serostatus.
  • Epstein-Barr virus (EBV)-seronegative or with unknown EBV serostatus.
  • Receipt of live (attenuated) vaccine within the 4 weeks before screening.
  • Participants with high potential of graft loss due to recurrence of underlying kidney disease.
  • Prior solid organ transplant or potential to require a concurrent organ or cell transplant.
  • Previous treatment with belatacept and cluster of differentiation 40 (CD40) or anti-CD40L agents.
  • Use of B cell depleting therapy, non-depleting B cell directed therapy e.g., belimumab or abatacept within 1 year prior to enrolment.
  • At screening blood tests any of the following:

    1. Aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN)
    2. Alanine aminotransferase (ALT) > 2.5 × ULN
    3. Alkaline phosphatase (ALP) > 2.5 × ULN
    4. Total bilirubin (TBL) > 2 × ULN
    5. Hemoglobin < 75 g/L
    6. Neutrophils < 1.5 × 10^9/L
    7. Platelets < 100 × 10^9/L
  • Participants with severe systemic infections, current or within the 2 weeks prior to transplant surgery.
  • Positive test for chronic hepatitis B infection at screening or within the last 12 months.
  • Positive test for hepatitis C virus antibody at screening or within the last 12 months.
  • Positive test for human immunodeficiency viruses antibody at screening or within the last 12 months.
  • History of or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless previously treated for latent tuberculosis.
  • History of cancer, except as follows:

    1. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; or
    2. Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy.
  • Lactating or pregnant females.

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): NCT04046549


Contacts
Layout table for location contacts
Contact: Horizon Therapeutics 1-866-479-6742 clinicaltrials@horizontherapeutics.com

Locations
Layout table for location information
United States, California
Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Christian Romero       christian.romero@med.usc.edu   
Principal Investigator: Jim Kim, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jun Shoji, MD       jun.shoji@ucsf.edu   
United States, North Carolina
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27710
Contact: Tresa Conca, RN, BSN       teresa.conca@duke.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ebony Taylor       EbonyS.Taylor@UTSouthwestern.edu   
Principal Investigator: David Wojciechowski, MD         
Sponsors and Collaborators
Viela Bio
Investigators
Layout table for investigator information
Study Director: Gabor Illei, MD Viela Bio
Layout table for additonal information
Responsible Party: Viela Bio
ClinicalTrials.gov Identifier: NCT04046549    
Other Study ID Numbers: VIB4920.P2.S1
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viela Bio:
Renal allograft dysfunction
Cell-mediated rejection
Antibody mediated rejection
Immunosuppression
Acute rejection
VIB4920
MEDI4920
Belatacept
Thymoglobulin
Methylprednisolone
Corticosteroids
Additional relevant MeSH terms:
Layout table for MeSH terms
Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents