Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
IGNAZ
A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ
The IGNAZ Study is looking at the safety and effectiveness of Felzartamab in adults 18 to 80 years old with IgA nephropathy. Researchers want to compare different doses of Felzartamab to see which one might be better than taking no medicine at all.
Intervencionista
Un ensayo clínico en el que se usa un nuevo medicamento o dispositivo para medir un resultado específico.
IGNAZ
A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ
The IGNAZ Study is looking at the safety and effectiveness of Felzartamab in adults 18 to 80 years old with IgA nephropathy. Researchers want to compare different doses of Felzartamab to see which one might be better than taking no medicine at all.
Criterios de elegibilidad
Población de pacientes
IgA nephropathy
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
¿Qué tratamientos pueden haber tomado los pacientes para calificar para este ensayo?
Inhibidores ACE/ARB, Prednisona (Esteroides), Rituximab (También conocido como Rituxan), 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
During the study you would first be screened to make sure you are eligible for treatment. If so, you would be placed by chance in a group to receive one of the Felzartamab or placebo doses. A placebo looks like the study treatment but has no actual medicine in it. A placebo is used to evaluate any potential difference in the benefits and side effects of felzartamab. The medicine and placebo are given as intravenous (IV) infusions, which means they are given slowly through a small needle in the arm. Each participant would receive a total of 9 infusions. You would also continue to take your current standard medicine (for example, blood pressure pills).
The study lasts a little over 2 years with 17 visits for tests. It comprises the screening period, treatment period and follow-up period in which you will allow the sponsor to access your medical history and biosamples such as blood and urine and perhaps biopsy tissue will be collected.
Nombre del patrocinador
MorphoSys AG
Fecha estimada de finalización
Last patient last visit January 2024
Sobre el estudio
Nombre del fármaco del estudio
MOR202/Felzartamab
Objetivo del estudio
IGNAZ seeks to investigate an innovative treatment option for IgA Nephropathy
Sobre el medicamento o la intervención
Felzartamab belongs to a group of medicines called “monoclonal antibodies”, proteins designed to attach to specific cells or substances in the body. Felzartamab is designed to attach to the cells that produce the antibody in your body and subsequently reduce unwanted auto-antibodies considered responsible for the development of IgA nephropathy.