NCT04174677

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

A Phase 2 Open-label, Prospective, Randomized Study of Inebilizumab, VIB4920, or the Combination to Evaluate Safety and Tolerability in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study acquired from Horizon in 2024.

Conditions

• Highly Sensitized Patients on Waiting List for Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Inebilizumab	Infusion of Inebilizumab
DRUG	VIB4920	Infusion of VIB4920
DRUG	Inebilzumab+VIB4920	Infusion of Inebilizumab and VIB4920

Timeline

• Start date: 2019-12-27
• Primary completion: 2021-12-01
• Completion: 2022-04-01
• First posted: 2019-11-22
• Last updated: 2024-06-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study