Un estudio para obtener más información sobre la seguridad y eficacia a largo plazo del molidustat como tratamiento para hombres y mujeres japoneses con anemia renal
Investigación a largo plazo del uso de drogas especiales de molidustat para pacientes con anemia renal
In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells.
In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat.
The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Many Locations, Japón
- Many locations
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label
Descripción
Inclusion Criteria:
- Female or male participants with a diagnosis of renal anemia
- Decision to initiate treatment with Molidustat was made as per investigator's routine treatment practice
- Molidustat naïve participants (with including the participants treated within three months before the contracted date at each site)
- Signed informed consent
Exclusion Criteria:
- Contra-indications according to the local marketing authorization
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Molidustat
Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators |
Tablets, administered orally at the discretion of investigators |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of safety events
Periodo de tiempo: Up to approximately 24 months
|
Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease (ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients |
Up to approximately 24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cambios absolutos de los niveles de hemoglobina (Hb) desde la línea de base
Periodo de tiempo: Hasta aproximadamente 24 meses
|
Hasta aproximadamente 24 meses
|
|
|
Cambios porcentuales de los niveles de hemoglobina (Hb) desde la línea de base
Periodo de tiempo: Hasta aproximadamente 24 meses
|
Hasta aproximadamente 24 meses
|
|
|
Evolución temporal de los niveles de Hb desde el inicio
Periodo de tiempo: Hasta aproximadamente 24 meses
|
Hasta aproximadamente 24 meses
|
|
|
Proporción de participantes con nivel de Hb dentro del rango objetivo
Periodo de tiempo: Hasta aproximadamente 24 meses
|
Hasta aproximadamente 24 meses
|
|
|
Incidence of safety events in dialysis and non-dialysis participants
Periodo de tiempo: Up to approximately 24 months
|
Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease(ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients |
Up to approximately 24 months
|
|
Incidence of safety events (important identified risk and important potential risk) by patient background
Periodo de tiempo: Up to approximately 24 months
|
Important identified risk: "Thromboembolism" and "Hypertension" Important potential risk: "Malignant tumor", "Retinal hemorrhage", "Major Adverse Cardiovascular Events (MACE) without thromboembolism", "Interstitial lung disease(ILD)" and "Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD)" |
Up to approximately 24 months
|
|
Absolute changes of Hb levels from baseline in sub-group analysis
Periodo de tiempo: Up to approximately 24 months
|
By patient background |
Up to approximately 24 months
|
|
Percentage changes of Hb levels from baseline in sub-group analysis
Periodo de tiempo: Up to approximately 24 months
|
By patient background |
Up to approximately 24 months
|
Colaboradores e Investigadores
Patrocinador
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
- 21319
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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.
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