Study Investigating Rapamune For Post-Marketing Surveillance
21 de noviembre de 2016 actualizado por: Pfizer
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors in the Korean population, such as:
- Unknown adverse reactions, especially serious adverse reactions
- To assess the incidence of adverse reactions under the routine drug uses
- Factors that may affect the safety of the drug (e.g., proteinuria)
- Factors that may affect the effectiveness of the drug
Descripción general del estudio
Descripción detallada
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Tipo de estudio
De observación
Inscripción (Actual)
209
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Daegu, Corea, república de, 705-717
- Yeungnam University Medical Center
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Gyeonggi-do, Corea, república de, 480-717
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Pusan, Corea, república de, 600-730
- Maryknoll Medical Center
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Seoul, Corea, república de, 135-710
- Samsung Medical Center
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Seoul, Corea, república de, 138-736
- Asan Medical Center
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Seoul, Corea, república de, 143-729
- Konkuk University Medical Center
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Seoul, Corea, república de, 136-705
- Korea University Anam Hospital
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Seoul, Corea, república de, 134-814
- Kangdong Sacred Heart Hospital
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Seoul, Corea, república de, 137-701
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Corea, república de, 135-720
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Corea, república de, 110-744
- Seoul National University Hospital (SNUH)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
13 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients who receive Rapamune after kidney transplantation
Descripción
Inclusion Criteria:
- Subjects aged 13 years or older receiving renal transplants, who are newly administered Rapamune after a contract is made between Pfizer Korea and an investigator and/or an institution for conducting this study.
Exclusion Criteria:
- Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients who have known hypersensitivity to Rapamune or its derivatives or any excipients in the formulation.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Rapamune
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Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
Periodo de tiempo: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized.
All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs.
Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.
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Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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Percentage of Participants With Clinically Significent Abnormal Laboratory Test
Periodo de tiempo: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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Laboratory test was not mandatory because this study was a non-interventional study.
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Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies
Periodo de tiempo: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Renal biopsy was required to confirm the diagnosis of acute rejection.
However, due to the non-interventional nature of this study, biopsy could not be mandatory.
The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Percentage of Participants Alive
Periodo de tiempo: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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The investigator recorded the participant's survival status and evaluation date on the CRF.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Percentage of Participants With Survived Graft
Periodo de tiempo: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Graft survival was defined as not showing graft loss at the time of evaluation.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula
Periodo de tiempo: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Graft function was evaluated by eGFR using Nankivell formula.
The investigator recorded the date of evaluation and the calculated value on the CRF.
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At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2011
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
7 de junio de 2007
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2007
Publicado por primera vez (Estimar)
8 de junio de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de enero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
21 de noviembre de 2016
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0468X1-4411
- B1741015 (Otro identificador: Alias Study Number)
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