Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
APPLAUSE-IgAN
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)
Brief Description
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023/iptacopan at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
Trial Physician / Study Coordinator
Michael Fechter
Email
Phone
(858) 401-7205
Site Name
Kaiser Permanente San Diego Dept. of Research & Evaluation
5251 Viewridge Ct., 2nd Floor, Suite 2031 San Diego, CA 92123
Sponsor
Novartis Pharmaceuticals
Study Drug
LNP023/iptacopan
Estimated enrollment
450 patients globally
Estimated end date
January 2025
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
APPLAUSE-IgAN
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)
Brief Description
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023/iptacopan at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
Trial is for people with
Primary IgA Nephropathy
Study Goal
The purpose of the study is to evaluate the efficacy and safety of LNP023/iptacopan compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients.
What is involved for the Patient?
Patients will be asked to attend a screening visit to assess eligibly. Medical history will be collected. The study team will collect biosamples (blood, urine, biopsy tissue). Visits may be in conjunction with normally scheduled appointments, but additional study visits may be required. If eligible, a patient will receive study medication or placebo on top of standard of care for approximately 2 years and be routinely assessed for safety and efficacy.
About the drug or intervention
LNP023/iptacopan is an investigational drug that we are studying as a potential targeted treatment for people with IgAN and other autoimmune diseases. The term "investigational" means that it is not currently approved for use by the general public. LNP023/iptacopan is thought to block a process in the body known to cause inflammation and kidney damage in people with IgAN and other autoimmune diseases. The APPLAUSE-IgAN trial will study the effects of LNP023/iptacopan on reducing inflammation and kidney damage in people with IgAN.
