Trial intelligence / Profile preview

Belimumab for Prevention of Allograft Rejection in Kidney Transplant

NCT01536379Phase 2

Key facts

Status
Completed
Start
Sep 2013
Primary completion
Feb 2016
Countries
1
Sponsor
GSK
Modality
Monoclonal Antibodies
Conditions
Allograft Rejection (AR)
01

Overview

Phase 2, randomised, double-blind trial of belimumab in Allograft Rejection (AR), sponsored by GSK. Started Sep 2013; status: completed.

02

Design

Study design
RandomizedDouble-blind
03

Who it enrols

Adults aged 18-75 undergoing kidney transplantation, planned to receive standard immunosuppression (basiliximab, MMF, tacrolimus, prednisolone).

04

Results

Not all primary endpoints met
05

Registry description

Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes a transplanted kidney is rejected by the patient's immune system. Many types of immune system cells, including B cells, are active in rejection. B cells produce antibodies against anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that help prevent transplant rejection affect cells other than B cells. Belimumab is a medication used to treat a disease called lupus. Belimumab slows development of antibody-producing B cells. This study will test whether belimumab…

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