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Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

25 de maio de 2011 atualizado por: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized Open-Label Study To Compare The Safety And Efficacy Of Conversion From A Calcineurin Inhibitor To Sirolimus Vs Continued Use Of A Calcineurin Inhibitor In Heart Transplant Recipients With Mild-Moderate Impaired Renal Function

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

121

Estágio

  • Fase 4

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

  • Austrália
    • New South Wales
      • Darlinghurst, New South Wales, Austrália, 2010
        • Pfizer Investigational Site
  • Canadá
      • Quebec, Canadá, G1V 4G5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canadá, H1T 1C8
        • Pfizer Investigational Site
      • Sainte-Foy, Quebec, Canadá, G1V 4G5
        • Pfizer Investigational Site
  • Espanha
      • Barcelona, Espanha, 08036
        • Pfizer Investigational Site
      • La Coru?a, Espanha, 15001
        • Pfizer Investigational Site
      • Madrid, Espanha, 28035
        • Pfizer Investigational Site
      • Sevilla, Espanha, 41013
        • Pfizer Investigational Site
      • Valencia, Espanha, 46009
        • Pfizer Investigational Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Espanha, 08907
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Espanha, 39008
        • Pfizer Investigational Site
  • Estados Unidos
    • Florida
      • Tampa, Florida, Estados Unidos, 33606
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Pfizer Investigational Site
    • New York
      • New York, New York, Estados Unidos, 10027-6902
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Estados Unidos, 19102
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23507
        • Pfizer Investigational Site
  • Nova Zelândia
      • Auckland, Nova Zelândia
        • Pfizer Investigational Site
    • Auckland
      • Epsom, Auckland, Nova Zelândia, 1003
        • Pfizer Investigational Site
  • Suíça
      • Bern, Suíça, 3010
        • Pfizer Investigational Site
  • Áustria
      • Vienna, Áustria, A-1090
        • Pfizer Investigational Site

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
  • 12 months after cardiac transplantation but less than 96 months post-transplantation.

Exclusion Criteria:

  • Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
  • Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
  • History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.

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

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 1
Group 1: Continuation of CNI regimen
Medicamento: cyclosporine or tacrolimus
Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
Outros nomes:
  • Brand names for cyclosporine are Neoral®, Sandimmune®, and Gengraf®; brand names for tacrolimus are Prograf® and Adagraf™.
Experimental: 2
Group 2: (CNI-Free) Conversion to SRL-based regimen
Medicamento: sirolimus
Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
Outros nomes:
  • Rapamune®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization
Prazo: Baseline and Week 52
Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.
Baseline and Week 52
Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline
Prazo: Baseline
Creatinine clearance at baseline calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization
Prazo: Baseline and Weeks 4, 16, 24, 32, and 40
Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.
Baseline and Weeks 4, 16, 24, 32, and 40
Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization
Prazo: Baseline and Weeks 4, 16, 24, 32, 40 and 52
Creatinine clearance calculated using MDRD equation. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function. Least squares mean adjusted for baseline calculated creatinine clearance (MDRD) and center.
Baseline and Weeks 4, 16, 24, 32, 40 and 52
Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline
Prazo: Baseline
Creatinine clearance calculated using MDRD equation. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.
Baseline
Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization
Prazo: Baseline and Weeks 4, 16, 24, 32, 40, and 52
Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week x minus baseline level where higher scores represented decreased kidney function. Least squares mean adjusted for treatment group and center.
Baseline and Weeks 4, 16, 24, 32, 40, and 52
Serum Creatinine Level at Baseline
Prazo: Baseline
Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine.
Baseline
Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)
Prazo: Baseline to discontinuation (up to Week 52)
The change in creatinine clearance over time assessed using the random coefficient slope of the regression line with creatinine clearance as the dependent variable and study day as the independent variable. Time points calculated as study days, relative to time of randomization of study medication. Observed data multiplied by a scale factor of 365 to express an annual change.
Baseline to discontinuation (up to Week 52)
Overall Survival (OS)
Prazo: Baseline until death (up to Week 56)
Survival time from the start of study treatment to date of death due to any cause, censored at the last visit if no death. Death was determined from the Death report. The distribution of time to death was to be estimated using Kaplan-Meier method and compared between treatment groups with a proportional hazard model. The number and percent of survival at 6 and 12 months were to be reported.
Baseline until death (up to Week 56)
Number of Participants With Acute Rejection
Prazo: Baseline to Week 52
Based on International Society for Heart and Lung Transplantation [ISHLT] 1990 criteria: rejections Grade 3A or higher, rejection accompanied by hemodynamic compromise or requiring treatment. Grade 3A or higher included: multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis. Biopsies performed for clinically suspected rejection (for cause), site's standard of care (site protocol biopsy), or protocol mandated.
Baseline to Week 52
Number of Participants With Biopsy-confirmed Acute Rejection by Severity
Prazo: Baseline to Week 52
Severity of acute rejection summarized using revised 2005 ISHLT criteria. Grade 0R: no rejection, Grade 1R: Focal (perivascular or interstitial) infiltrate without necrosis, diffuse but sparse infiltrate without necrosis, or one focus only with aggressive infiltration and/or focal myocyte damage, Grade 2R:Multifocal aggressive infiltrates and/or myocyte damage, and Grade 3R:Diffuse inflammatory process with necrosis, or diffuse aggressive polymorphous with necrosis, increased infiltrate, changes in edema, hemorrhage and vasculitis.
Baseline to Week 52
Time to First Acute Rejection
Prazo: Baseline to Week 52
Time from baseline to first biopsy-confirmed acute rejection defined as any of the following (based on ISHLT 1990 criteria): all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.
Baseline to Week 52
Number of Participants Requiring Antibody Use in Treatment of Acute Rejection
Prazo: Baseline to Week 52
Number of participants requiring antilymphocyte antibody therapy with suspected or biopsy-proven, steroid-resistant, acute rejection with or without hemodynamic compromise. Acute rejection based on ISHLT 1990 criteria: all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.
Baseline to Week 52
Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy
Prazo: Baseline up to Week 52
Baseline up to Week 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Wyeth is now a wholly owned subsidiary of Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

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 setembro de 2006

Conclusão Primária (Real)

1 de abril de 2010

Conclusão do estudo (Real)

1 de maio de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

25 de agosto de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de agosto de 2006

Primeira postagem (Estimativa)

29 de agosto de 2006

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

30 de maio de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de maio de 2011

Última verificação

1 de maio de 2011

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 0468E7-408
  • B1741006 (Outro identificador: Pfizer)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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