Summary

for people ages 18-70 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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.

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

Keywords

Allografts Rejection; Transplant, Kidney Transplant Rejection Kidney Transplantation Renal allograft dysfunction Cell-mediated rejection Antibody mediated rejection Immunosuppression Acute rejection VIB4920 MEDI4920 Belatacept Thymoglobulin Methylprednisolone Corticosteroids Abatacept Belatacept+VIB4920

Eligibility

You can join if…

Open to people ages 18-70

  • 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:
  • No donor specific antibodies (DSA), and
  • 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.

You CAN'T join if...

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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Duke University School of Medicine not yet accepting patients
    Durham North Carolina 27710 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Viela Bio
ID
NCT04046549
Phase
Phase 2
Study Type
Interventional
Last Updated