Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
R3R01: AS-FSGS
R3R01: AS-FSGS
Breve descripción
A Phase II, Multi-center, Open-Label Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of R3R01 in Alport Syndrome Patients with uncontrolled Proteinuria on ACE/ARB Inhibition, and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis.
Médico del ensayo/Coordinador del estudio
Oscar Lemus
Correo electrónicoNombre del sitio
Academic Medical Research Institute
5830 E Whittier Blvd. Los Angeles, 90022, California
Nombre del patrocinador
R3R Corp
Nombre del fármaco del estudio
R3R01
Matrícula estimada
20 AS and 30 FSGS patients
Fecha estimada de finalización
Last patient enrolled July 2024
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
R3R01: AS-FSGS
R3R01: AS-FSGS
Breve descripción
A Phase II, Multi-center, Open-Label Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of R3R01 in Alport Syndrome Patients with uncontrolled Proteinuria on ACE/ARB Inhibition, and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis.
El ensayo es para personas con
Alport syndrome and primary focal segmental glomerulosclerosis (FSGS)
Objetivo del estudio
The goal of this 12-week open-label study is to determine if R3R01 reduces proteinuria.
Qué implica para el paciente?
All patients will receive R3R01 as an oral tablet twice daily for 12 weeks. Blood and urine will be collected, physical exams including vital signs and electrocardiograms will be performed. Patients will be required to attend study visits weekly for the first month, then monthly for the remainder of treatment and 3-month follow-up.
Sobre el medicamento o la intervención
R3R01 is an orally administered small molecule that targets a novel mechanism by increasing levels of functional ABCA1 and cholesterol efflux with the aim of reducing pathologic levels of intracellular (kidney) lipids.