Un estudio para obtener más información sobre la seguridad y los efectos a largo plazo de las infusiones de felzartamab en adultos con trasplante de riñón que tienen rechazo mediado por anticuerpos (RMA)
Un estudio de extensión abierto a largo plazo para participantes del estudio 299AR301 con felzartamab
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI). AMR happens when the body's immune system creates donor-specific antibodies (DSAs) that attack the transplanted kidney. In late AMR, this typically happens more than 6 months after the kidney transplant. MVI is a condition where the small blood vessels in the transplanted kidney become inflamed. MVI can happen with or without DSAs. Both AMR and MVI can cause the transplanted kidney to stop working properly.
Two earlier studies looked at felzartamab in kidney transplant recipients. Study 299AR301 (TRANSCEND) (NCT06685757) included participants with AMR. Study 299AR201 (TRANSPIRE) (NCT07219043) included participants with MVI.
This study, 299AR302-299AR301 LTE, is a long-term extension of both of these "parent" studies. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years after completing their parent study.
The goal of this study is to learn more about the long-term safety and effects of felzartamab in people with kidney transplants. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302.
The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug.
Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health.
The study will be done as follows:
- Participants who complete the final visit of the treatment period in one of the parent studies can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits.
- Participants who did not stop receiving felzartamab in their parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time.
- Participants who stopped receiving felzartamab in their parent study will only attend study visits for health monitoring- they will not receive felzartamab.
- Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle.
- Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit after their final dose.
- Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The primary objective of this study is to evaluate the long-term safety of felzartamab. The secondary objectives of this study are to describe the ongoing efficacy of felzartamab on biopsy-proven histologic response (BPHR), microvascular inflammation (MVI) and graft function; and to evaluate pharmacokinetics (PK) and immunogenicity of felzartamab.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V6Z1Y6
- Providence Health Care - St. Paul's Hospital
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California
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Estados Unidos, 90033
- Keck Medical Center of USC
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Los Angeles, California, Estados Unidos, 90095
- UCLA College of Medicine
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San Francisco, California, Estados Unidos, 94115
- California Pacific Medical Center (Sutter Health)
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198-3040
- University of Nebraska Medical Center (UNMC) - Nebraska Medicine - Nebraska Medical Center
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New Jersey
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West Orange, New Jersey, Estados Unidos, 07039
- Cooperman Barnabas Medical Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Penn Medicine - Hospital of the University of Pennsylvania
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
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Have completed the parent study Week 52 visit or will be completing Week 52 visit procedures (for participants who sign consent before reaching the Week 52 visit).
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Have received at least one dose of felzartamab in the parent studies, and had the following disposition status in the parent study:
- Ongoing Treatment: Did not discontinue felzartamab treatment in the parent study and received a dose at the Week 44 visit.
- Treatment Interrupted: Did not discontinue felzartamab treatment in the parent study and did not receive a dose at the Week 44 visit.
- Off Treatment, On Study: Discontinued felzartamab treatment in the parent study and were not withdrawn from the study.
Participants who discontinued study treatment prior to receiving any doses of felzartamab in the parent study (i.e., those in the placebo group who discontinued before receiving felzartamab) are not eligible for enrollment in this substudy.
- For participants enrolling into this study who have not discontinued felzartamab treatment in the parent study only: The Investigator has determined that the participant could benefit from continued felzartamab treatment.
Key Exclusion Criteria:
- Met a treatment discontinuation criterion in the parent study but treatment was not discontinued (for example, because the criterion was met after the last dose of felzartamab in the parent study).
Note: Other protocol-defined inclusion/exclusion criteria apply.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Felzartamab: Long-Term Extension Treatment
Participants will receive multiple IV doses of felzartamab. |
Administered IV
Otros nombres:
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Experimental: Felzartamab: Off-Treatment Observation
Participants who were off treatment but still continued participating in the respective parent study at the time of enrollment into the LTE or who have discontinued felzatamab treatment after receiving one or more doses in this substudy will be encouraged to continue being followed off-treatment. |
Administered IV
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Número de participantes con eventos adversos (EA), eventos adversos graves (EAG) y eventos adversos de interés especial (EAEI)
Periodo de tiempo: Desde la primera dosis del fármaco del estudio hasta el final del seguimiento del estudio (hasta la semana 204)
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Desde la primera dosis del fármaco del estudio hasta el final del seguimiento del estudio (hasta la semana 204)
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Número de Participantes que Interrumpen el Tratamiento debido a un EA
Periodo de tiempo: Desde la primera dosis del fármaco del estudio hasta el final del seguimiento del estudio (hasta la semana 204)
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Desde la primera dosis del fármaco del estudio hasta el final del seguimiento del estudio (hasta la semana 204)
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Número de participantes con anomalías clínicamente significativas en pruebas de laboratorio, signos vitales y electrocardiogramas (ECG)
Periodo de tiempo: Desde la primera dosis del fármaco del estudio hasta la visita final del ensayo (hasta la semana 200)
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Desde la primera dosis del fármaco del estudio hasta la visita final del ensayo (hasta la semana 200)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Porcentaje de participantes que logran resolución histológica comprobada por biopsia (BPHR)
Periodo de tiempo: Hasta la semana 200
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Hasta la semana 200
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Puntuación de Inflamación Microvascular (MVI)
Periodo de tiempo: Hasta la Semana 200
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Hasta la Semana 200
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Cambio desde el valor basal en la tasa de filtración glomerular estimada (TFGe)
Periodo de tiempo: Línea de base, semana 200
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Línea de base, semana 200
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Tiempo hasta la pérdida del aloinjerto por cualquier causa
Periodo de tiempo: Hasta la semana 200
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Hasta la semana 200
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Tiempo hasta la muerte o pérdida censurada del aloinjerto
Periodo de tiempo: Hasta la Semana 204
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Hasta la Semana 204
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Concentración Sérica de Felzartamab
Periodo de tiempo: A la semana 200
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A la semana 200
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Número de participantes con anticuerpos antifármaco (ADA) contra felzartamab
Periodo de tiempo: A la Semana 200
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A la Semana 200
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Percentage of Participants Achieving an MVI Score of 0 by Each Biopsy Timepoint
Periodo de tiempo: Up to Week 200
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Up to Week 200
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Change From Baseline in Proteinuria
Periodo de tiempo: Baseline, Week 200
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Baseline, Week 200
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Medical Director, Biogen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 299AR302-299AR301-LTE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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