RAINIER
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled study of Povetacicept in Adults with Immunoglobulin A Nephropathy (RAINIER)
IRAS ID
1010364
Contact name
Anna Sedello
Contact email
Sponsor organisation
Alpine Immune Sciences, Inc.
Research summary
This study tests if a new medicine named povetacicept can help people with immunoglobulin A nephropathy (IgAN). BAFF and APRIL are proteins in human blood that help a type of white blood cell called “B cells” become cells that make antibodies. Antibodies are proteins used by the body to defend itself against infections. In diseases like IgAN, the body’s antibodies damage the kidney, which can cause blood and protein to leak into the urine (pee). This can make people sick and stop the kidneys from working. Povetacicept was designed to make BAFF and APRIL stop working on B cells and, therefore, stop the body from making antibodies that attack the kidney. This may slow down kidney damage and help the kidneys work longer in people with IgAN. Every person in the study will receive 26 doses of povetacicept or placebo. The doses will be given every 4 weeks for 2 years (104 weeks). For each dose, there will be 1 injection given under the skin.
The main goals of the study are to:
• Learn how well povetacicept works in people with IgAN to lower the amount of protein in the urine
• See how well povetacicept works in people with IgAN to slow down kidney damage and keep the kidneys working longer.A secondary goal of the study is to see how well povetacicept works to help people with IgAN feel less tired.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0619
Date of REC Opinion
15 Oct 2024
REC opinion
Further Information Favourable Opinion