A multi-center randomized double-blind placebocontrolled parallel group phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Brief description of study

The purpose of the study is to find out if LNP023 (also called iptacopan) is safe and effective in people who have primary IgA Nephropathy. IgA Nephropathy is a kidney disease that occurs when a mutated form of immunoglobulin A (IgA) is made by the body, and triggers an autoimmune response which in turn leads to inflammation that, over time, may interfere with the kidneys' ability to filter wastes from blood. The alternative complement pathway (AP) is an important system in the body which provides protection against infections, however, an over-activated AP is believed to contribute to kidney inflammation and worsening of the IgA Nephropathy condition. LNP023 blocks key steps in the AP that may improve IgA Nephropathy.

Clinical Study Identifier: s21-00306
ClinicalTrials.gov Identifier: NCT04578834
Principal Investigator: Olga Zhdanova.
Other Investigator: Nina J Caplin.

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