Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
ASSIST
A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodiumglucose Cotransporter-2 Inhibitors (SGLT2i).
A study to learn if atrasentan is safe and works in people with IgA nephropathy who are taking an SGLT2 inhibitor.
Médico del ensayo/Coordinador del estudio
Amy Bottomlee
Correo electrónico
Número de teléfono
(205) 975-4482
Nombre del sitio
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Nephrology Clinic
701 20th Street South, Birmingham, AL, 35294
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
ASSIST
A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodiumglucose Cotransporter-2 Inhibitors (SGLT2i).
A study to learn if atrasentan is safe and works in people with IgA nephropathy who are taking an SGLT2 inhibitor.
Criterios de elegibilidad
Población de pacientes
IgA nephopathy
Edad
18 — 26+
¿Pueden los pacientes con trasplante de riñón calificar para este ensayo?
No
¿Los pacientes que se encuentran actualmente en diálisis pueden calificar para este ensayo?
No
TFGe
30 a 44 — > 60
UPCR
1,1 a 2,0 — 3,0 o más
¿Qué tratamientos pueden haber tomado los pacientes para calificar para este ensayo?
Inhibidores ACE/ARB, Otro
¿Qué tipo de pacientes de las categorías siguientes pueden participar?
Ninguno de estos
Sobre el medicamento o la intervención
Qué implica para el paciente
This is a phase 2, double-blind, placebo-controlled, crossover study. All the participants will take all the study treatments (atrasentan and a placebo), but in a different order. Participants will take study treatment for up to 36 weeks but will be in the study for up to 64 weeks. Participants must already be taking an SGLT2i before joining the study or be willing to start taking an SGLT2i during the study. Participants will complete up to 14 study site visits and up to 11 remote visits. Both atrasentan and the placebo are taken as tablets by mouth. Participants will continue to take an SGLT2i throughout the entire study. During the study, the study doctors will monitor the participants’ health by testing their blood and urine, performing physical exams and checking their heart function with an electrocardiogram.
Nombre del patrocinador
Chinook Therapeutics, a Novartis Company
Fecha estimada de finalización
Jan 2025
Sobre el estudio
Nombre del fármaco del estudio
Atrasentan
Objetivo del estudio
ASSIST seeks to evaluate the efficacy of atrasentan vs placebo while on background therapy with SGLT2i
Sobre el medicamento o la intervención
The study drug, atrasentan, is designed to work by blocking a specific pathway in the kidneys, preventing it from causing negative effects that damage the kidneys. Blocking this pathway may help to prevent kidney damage and may even help the kidneys work better. All participants in this study will also be taking an SGLT2 inhibitor (SGLT2i). An SGLT2i is a drug that is used to treat chronic kidney disease. Chronic kidney disease is a condition in which the kidneys stop working over time due to kidney damage. Researchers think that giving atrasentan with an SGLT2i could prevent kidney damage over time.
