Estudio intervencionista
un ensayo clínico en el que se utiliza un nuevo fármaco 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
El estudio IGNAZ analiza la seguridad y eficacia de Felzartamab en adultos de 18 a 80 años con nefropatía por IgA. Los investigadores quieren comparar diferentes dosis de Felzartamab para ver cuál podría ser mejor que no tomar ningún medicamento.
Estudio intervencionista
un ensayo clínico en el que se utiliza un nuevo fármaco 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
El estudio IGNAZ analiza la seguridad y eficacia de Felzartamab en adultos de 18 a 80 años con nefropatía por IgA. Los investigadores quieren comparar diferentes dosis de Felzartamab para ver cuál podría ser mejor que no tomar ningún medicamento.
Eligibility Criteria
Patient Population
IgA nephropathy
Age
18 — 26+
History of transplant allowed?
No
History of dialysis allowed?
No
eGFR
UPCR
Not Sure
Permitted medication history
Ace Inhibitors/ARB, Prednisone (Steroids), Rituximab (AKA Rituxan), Other
Patient should be
Neither of These
About the Drug
What is involved for the patient
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.
Sponsor
MorphoSys AG
Estimated End Date
Last patient last visit January 2024
About the Trial
Study Drug
MOR202/Felzartamab
Study Goal
IGNAZ seeks to investigate an innovative treatment option for IgA Nephropathy
About the drug or intervention
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.