Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor

Conditions

• Highly Sensitized Patients on Waiting List for Kidney Transplantation

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Inebilizumab — DRUG
  Infusion of Inebilizumab
• VIB4920 — DRUG
  Infusion of VIB4920
• Inebilzumab+VIB4920 — DRUG
  Infusion of Inebilizumab and VIB4920

Study Details

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.

Key Dates

Start date

Dec 27, 2019

Status verified

Jun 2024

Primary completion

Dec 31, 2021

Completion

Apr 30, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Inebilzumab Treatment
  Infusion of Inebilizumab
• Experimental: VIB4920 Treatment
  Infusion of VIB4920
• Experimental: Inebilzumab+VIB4920 Treatment
  Infusion of Inebilizumab and VIB4920

Primary Outcome Measure

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 [ Time Frame: Through study completion, an average of 1 year ]

Locations (2)

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