Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
SANCTUARY
Phase 2 ALXN1210-NEPH-202 Study
Breve descripción
The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against disease) of the study medication (ALXN1210 also known as ravulizumab or ULTOMIRIS ®) in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease.
Nombre del sitio
Fort Worth, TX
76104
Nombre del patrocinador
Alexion, Astra Zeneca Rare Disease
Nombre del fármaco del estudio
ALXN1210 also known as ravulizumab or ULTOMIRIS
Matrícula estimada
120
Fecha estimada de finalización
September 2024
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
SANCTUARY
Phase 2 ALXN1210-NEPH-202 Study
Breve descripción
The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against disease) of the study medication (ALXN1210 also known as ravulizumab or ULTOMIRIS ®) in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease.
El ensayo es para personas con
IgA Nephropathy or Lupus Nephritis
Objetivo del estudio
This randomized placebo-controlled dose-finding study is to evaluate the safety of ALXN1210 in adult participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN).
Qué implica para el paciente?
This study will include 120 participants, 60 with LN and 60 with IgAN. The total study duration for each participant will be approximately 2 years. This clinical trial is a phase 2 randomized placebo controlled clinical trial that is randomized 2:1 treatment to placebo such that if you are enrolled you are twice as likely to receive the study treatment than the placebo. Before you choose to participate, you should speak with your doctor.
Sobre el medicamento o la intervención
The study medication is administered intravenously every 8 weeks.