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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

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ClinicalTrials.gov Identifier: NCT04046549
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Viela Bio

Tracking Information
First Submitted Date  ICMJE August 2, 2019
First Posted Date  ICMJE August 6, 2019
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE October 30, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Allografts
  • Rejection; Transplant, Kidney
  • Transplant Rejection
  • Kidney Transplantation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Belatacept
  • Drug: VIB4920
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, have adequate central laboratory test results.
  • Participants with severe systemic infections, current or within the 2 weeks prior to transplant surgery.
  • Positive test for chronic hepatitis B infection at screening.
  • Positive test for hepatitis C virus antibody.
  • Positive test for human immunodeficiency viruses antibody.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Falleroni 240-558-0038 FalleroniD@vielabio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04046549
Other Study ID Numbers  ICMJE VIB4920.P2.S1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Viela Bio
Study Sponsor  ICMJE Viela Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gabor Illei, MD Viela Bio
PRS Account Viela Bio
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP