Study Investigating Rapamune For Post-Marketing Surveillance
21 de novembro de 2016 atualizado 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
Visão geral do estudo
Descrição detalhada
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Tipo de estudo
Observacional
Inscrição (Real)
209
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Daegu, Republica da Coréia, 705-717
- Yeungnam University Medical Center
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Gyeonggi-do, Republica da Coréia, 480-717
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Pusan, Republica da Coréia, 600-730
- Maryknoll Medical Center
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Seoul, Republica da Coréia, 135-710
- Samsung Medical Center
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Seoul, Republica da Coréia, 138-736
- Asan Medical Center
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Seoul, Republica da Coréia, 143-729
- Konkuk University Medical Center
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Seoul, Republica da Coréia, 136-705
- Korea University Anam Hospital
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Seoul, Republica da Coréia, 134-814
- Kangdong Sacred Heart Hospital
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Seoul, Republica da Coréia, 137-701
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Republica da Coréia, 135-720
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Republica da Coréia, 110-744
- Seoul National University Hospital (SNUH)
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
13 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients who receive Rapamune after kidney transplantation
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2011
Conclusão Primária (Real)
1 de junho de 2015
Conclusão do estudo (Real)
1 de junho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
7 de junho de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de junho de 2007
Primeira postagem (Estimativa)
8 de junho de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
16 de janeiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de novembro de 2016
Última verificação
1 de novembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0468X1-4411
- B1741015 (Outro identificador: Alias Study Number)
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