Estudio intervencionista
un ensayo clínico en el que se utiliza un nuevo fármaco o dispositivo para medir un resultado específico.
RAINIER
RAINIER
Breve descripción
RAINIER is a clinical research study for adults with immunoglobulin A nephropathy (IgAN).
Médico del ensayo / Coordinador del estudio
Ella Marovari
Correo electrónicoNombre del sitio
Boise Kidney & Hypertension PLLC- Meridian
3525 E. Louise Suite 195, Meridian ID, 83642
Patrocinador
Vertex Pharmaceuticals
Fármaco del estudio
Povetacicept
Matrícula estimada
480
Fecha de finalización estimada
May 29th, 2026
Estudio intervencionista
un ensayo clínico en el que se utiliza un nuevo fármaco o dispositivo para medir un resultado específico.
RAINIER
RAINIER
Breve descripción
RAINIER is a clinical research study for adults with immunoglobulin A nephropathy (IgAN).
La prueba es para personas con
immunoglobulin A nephropathy (IgAN)
Objetivo del estudio
This study is measuring the safety and effectiveness of the study drug compared to placebo in participants with IgA nephropathy.
¿Qué implica para el paciente?
Study participation is a little longer than 2 years. Study Participants will attend in-person study visits to receive the study treatment and participate in study assessments every 4 weeks. Study participants can expect the following:
a. Screening Period (up to 6 weeks): You will receive study health assessments to confirm if you qualify for the study. These assessments include physical exam, medical history review, electrocardiogram (ECG), vital signs, blood tests, and urine tests.
b. Study Treatment Period (Every 4 weeks over 2 Years): Participants are assigned at random to receive study treatment with either povetacicept (the investigational drug) or placebo. The placebo looks identical to povetacicept but does not have active ingredients. You will receive an injection of your assigned study treatment every 4 weeks for a total of 26 doses.
c. Follow-up Period (12 Weeks): Your final study assessment will be 12 weeks after your last dose.
Sobre el medicamento o la intervención
The study drug is an injection given once every 4 weeks just under the skin in the arm, thigh, or belly. It might block 2 proteins (BAFF and APRIL) that contribute to kidney inflammation from IgAN.