Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
APPLAUSE-IgAN
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)
Breve descripción
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.
Médico del ensayo/Coordinador del estudio
Johanna Rico
Correo electrónico
Número de teléfono
(831) 755-7999
Nombre del sitio
Central Coast Nephrology
917 Blanco Circle Salinas, CA 93901
Nombre del patrocinador
Novartis Pharmaceuticals
Nombre del fármaco del estudio
LNP023/iptacopan
Matrícula estimada
450 patients globally
Fecha estimada de finalización
January 2025
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
APPLAUSE-IgAN
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)
Breve descripción
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.
El ensayo es para personas con
Primary IgA Nephropathy
Objetivo del estudio
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.
Qué implica para el paciente?
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.
Sobre el medicamento o la intervención
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.
