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Felzartamab

A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)

Ensayo de BIOGEN INC. en Rechazo mediado por anticuerpos · Inflamacion microvascular.

Fase: Fase 3
Estado: Reclutando por invitación
Participantes: 201
Centros: 13
Fin del objetivo primario: dic 2031

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2026.

Lo que ha cambiado

Movimientos registrados desde que PivotalWire vigila este ensayo. Un retraso no se anuncia: se ve comparando, y esto es la comparación ya hecha.

Visto	Qué se mueve	Cambio
1 oct 2026	Lectura de resultados	may 2031 → dic 2031

Qué mide

Numero de participantes con acontecimientos adversos (AE), acontecimientos adversos graves (SAE) y acontecimientos adversos de interes especial (AESI) (From first dose of study drug up to end of study follow-up (Up to Week 204)) (del registro, en inglés)

Qué se prueba

Se va a seguir observando durante hasta 4 años más a personas con trasplante de riñón que recibieron felzartamab en estudios previos, para conocer más sobre su seguridad a largo plazo y sus efectos en la inflamación, la función renal y la actividad inmunológica.

Lo que dice el documentoThis 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.

Traducción automática (claude-haiku-4-5-20251001). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn 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.

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Ficha completa en ClinicalTrials.gov (NCT07444489), actualizada en sep 2026.