Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy (The BEYOND Study)
IRAS ID
1007914
Contact name
Sophia Siu
Contact email
Sponsor organisation
Chinook Therapeutics, Inc.
Eudract number
2023-503743-34
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Patients with immunoglobulin A nephropathy (IgAN) and are at risk for losing their kidney function. Immunoglobulin A is an antibody (a protein in the blood that helps the body’s defenses by finding and attaching to foreign substances, like germs, and protect you against them). IgAN is caused when the body’s defense system (immune system) does not work the way it is supposed to. The body produces some abnormal immunoglobulin A antibodies which build up in the kidneys, and can cause the kidneys to stop working properly.
About 292 adults will take part in this study worldwide. This study will be conducted at about 200 study sites worldwide.
The study will test an experimental drug named BION-1301. BION-1301 is a new drug that is being developed for treating people with IgAN.
The goal of this study is to see if BION-1301 has an effect on how well the kidneys work by measuring the level of protein in the urine (proteinuria) and how well the kidneys are filtering (estimated glomerular filtration rate) the blood. The study is also designed to see how well people with IgAN accept treatment with BION-1301, and to see if BION 1301 is safe for people in the study when compared to the placebo (a substance that looks like BION-1301 but does not have any medicine in it).
8 research sites (7 NHS and 1 non-NHS) are planned to participate in the UK.
Total duration for study participation per subject is expected to be up to 134 weeks.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0179
Date of REC Opinion
4 Oct 2023
REC opinion
Further Information Favourable Opinion