Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
FSGS Clinical Research Study
A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS)
Breve descripción
This study is being done to see if the study drug, called BI 764198, may help people with FSGS. The study drug or a placebo will be taken as a capsule by mouth one (1) time every day for about 12 weeks.
Médico del ensayo/Coordinador del estudio
Moravia Vasallo
Correo electrónico
Número de teléfono
915-306-4669
Nombre del sitio
MedResearch, Inc.
1201 East Schuster Avenue, BLDG 1 A
Nombre del patrocinador
Boehringer Ingelheim Pharmaceuticals, Inc.
Nombre del fármaco del estudio
BI 764198
Matrícula estimada
60 patients globally
Fecha estimada de finalización
October 2024
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
FSGS Clinical Research Study
A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS)
Breve descripción
This study is being done to see if the study drug, called BI 764198, may help people with FSGS. The study drug or a placebo will be taken as a capsule by mouth one (1) time every day for about 12 weeks.
El ensayo es para personas con
Primary FSGS or documented Transient Receptor Potential Cation subfamily C Member 6 (TRPC6) gene mutation causing FSGS.
Objetivo del estudio
This study is being done to:
• Test different doses of the study drug, BI 764198, for safety, effectiveness, and side effects, when compared to taking a placebo, in subjects with focal segmental glomerulosclerosis (FSGS).
In this study, you will either get the active study drug, BI 764198, or a placebo.
• Test how the study drug is used by the body, and how fast or slow the study drug moves through or out of the body.
Qué implica para el paciente?
Patients will be asked to allow researchers to access medical history. This trial consists of a Screening Period, a Study Drug Period, an End of Treatment Visit, and a Follow-Up Period. There are about 10 visits and 1 phone call visit to participate in the trial. The study staff or study doctor may complete the following procedures during each study visit: ECG, 24 hour urine collection (instructions/collection diary distribution), collect lab samples for safety testing (blood or urine), collect biomarker samples (blood or urine) which is optional, Pharmacokinetic (PK) samples (urine), and eye exams.
Sobre el medicamento o la intervención
BI 764198 is taken orally as a capsule once daily.
