Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candida… (NCT04174677) | Clinical Trial Compass
WithdrawnPhase 2
Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Stopped: Stopped due to no enrollment
United States0Started 2019-12-27
Plain-language summary
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation. Eligible subjects will be randomized to one of three treatment arms, administered the investigational products as an intervention and subsequently followed for safety.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subjects with ESRD who are maintained on hemodialysis.
✓. Subjects awaiting first or second kidney transplantation from a deceased donor.
✓. Subjects with cPRA 98 100% at Screening Visit 1, calculated using antibodies with titer ≥ 1:16 and/or MFI value ≥ 1400, verified by the central laboratory.
✓. Subjects with stable anti-HLA antibody titers (a difference of \< 2 titers versus the average titer of antibodies compared to the screening sample) based on 2 legacy samples drawn within 6 to 12 months prior to Screening Visit 1, verified by the central laboratory.
Exclusion criteria
✕. Subjects awaiting kidney transplantation from a living donor.
✕. Subjects who have previously undergone desensitization with plasmapheresis/plasma exchange, IVIG, rituximab, imlifidase, tocilizumab or a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib, others) within 12 months prior to randomization.
✕. Candidates for a second kidney allograft if the first allograft was lost within 12 months prior to screening.
✕. Subjects who have experienced a sensitizing event (eg, pregnancy, blood transfusion) within 6 months prior to screening.
✕. Recipients of a prior non-kidney organ transplant or stem cell transplant.
✕. Subjects treated with systemic immunosuppressive drug therapy for more than a total of 2 weeks within 12 months prior to ICF signature (treatment with corticosteroids \< 10 mg/day PO prednisone or equivalent for less than a total of 2 weeks during the 4 weeks prior to screening is allowed).
What they're measuring
1
Number of subjects with safety events (treatment-emergent adverse events, treatment-emergent serious adverse events, or treatment-emergent adverse events of special interest) during the course of the study
Timeframe: Through study completion, an average of 1 year