Phase 2
Completed N=23
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
Allografts · Rejection; Transplant, Kidney · Transplant Rejection · Chronic Kidney Disease
Source: ClinicalTrials.gov NCT04046549 ↗
Enrolled (actual)
23
Serious AEs
43.5%
Results posted
Oct 2023
Primary outcomePrimary: Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24 — 25.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24 |
25.0 | — |
| SECONDARY Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48 |
25.0; 25.0 | — |
| SECONDARY Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU) |
25.0; 25.0; 25.0 | — |
| SECONDARY Percentage of Participants With Antibody-Mediated Rejection |
10.0; 10.0; 15.0 | — |
| SECONDARY Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) |
25.0; 25.0; 25.0 | — |
| SECONDARY Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) |
25.0; 25.0; 25.0 | — |
| SECONDARY Percentage of Participants With Treated Acute Rejections |
25.0; 25.0; 30.0 | — |
| SECONDARY Percentage of Participants With De Novo Donor-specific Antibodies (dnDSA) |
— | — |
Eligibility 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:
- 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.
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:
- Aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN)
- Alanine aminotransferase (ALT) > 2.5 × ULN
- Alkaline phosphatase (ALP) > 2.5 × ULN
- Total bilirubin (TBL) > 2 × ULN
- Hemoglobin 12 months prior to screening; or
- Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy.
- Lactating or pregnant females.
Data sourced from ClinicalTrials.gov (NCT04046549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.