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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 mayo de 2011 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

121

Fase

  • Fase 4

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

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
  • Austria
      • Vienna, Austria, A-1090
        • 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
  • España
      • Barcelona, España, 08036
        • Pfizer Investigational Site
      • La Coru?a, España, 15001
        • Pfizer Investigational Site
      • Madrid, España, 28035
        • Pfizer Investigational Site
      • Sevilla, España, 41013
        • Pfizer Investigational Site
      • Valencia, España, 46009
        • Pfizer Investigational Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, España, 08907
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, España, 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
  • Nueva Zelanda
      • Auckland, Nueva Zelanda
        • Pfizer Investigational Site
    • Auckland
      • Epsom, Auckland, Nueva Zelanda, 1003
        • Pfizer Investigational Site
  • Suiza
      • Bern, Suiza, 3010
        • Pfizer Investigational Site

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

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

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 1
Group 1: Continuation of CNI regimen
Droga: 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.
Otros nombres:
  • 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
Droga: 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.
Otros nombres:
  • Rapamune®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline up to Week 52
Baseline up to Week 52

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Wyeth is now a wholly owned subsidiary of Pfizer

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.

Publicaciones Generales

Enlaces Útiles

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 septiembre de 2006

Finalización primaria (Actual)

1 de abril de 2010

Finalización del estudio (Actual)

1 de mayo de 2010

Fechas de registro del estudio

Enviado por primera vez

25 de agosto de 2006

Primero enviado que cumplió con los criterios de control de calidad

25 de agosto de 2006

Publicado por primera vez (Estimar)

29 de agosto de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de mayo de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

25 de mayo de 2011

Última verificación

1 de mayo de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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