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Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (INTAC)

9 de agosto de 2011 actualizado por: Astellas Pharma Inc

Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Tipo de estudio

Intervencionista

Inscripción (Actual)

501

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

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
    • California
      • Los Angeles, California, Estados Unidos, 90057
      • Palo Alto, California, Estados Unidos, 94304
      • San Diego, California, Estados Unidos, 92123
      • San Francisco, California, Estados Unidos, 94115
      • San Francisco, California, Estados Unidos, 94143
    • Colorado
      • Denver, Colorado, Estados Unidos, 80262
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20010
      • Washington, District of Columbia, Estados Unidos, 20007
    • Florida
      • Miami, Florida, Estados Unidos, 33136
      • Tampa, Florida, Estados Unidos, 33066
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
      • Chicago, Illinois, Estados Unidos, 60612
    • New Jersey
      • Livingston, New Jersey, Estados Unidos, 07039
      • New Brunswick, New Jersey, Estados Unidos, 08901
    • New York
      • Hawthorne, New York, Estados Unidos, 10532
      • New York, New York, Estados Unidos, 10032
      • New York, New York, Estados Unidos, 10029
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
      • Durham, North Carolina, Estados Unidos, 27710
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45267
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
    • Pennsylvania
      • Danville, Pennsylvania, Estados Unidos, 17822
      • Harrisburg, Pennsylvania, Estados Unidos, 17105
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
      • Milwaukee, Wisconsin, Estados Unidos, 53226

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:

  • Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).

Exclusion Criteria:

  • Patient has previously received an organ transplant other than a kidney
  • Patient receiving chronic steroid therapy at time of transplant

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Droga: tacrolimus
oral
Otros nombres:
  • Prograf, FK506
Droga: micofenolato de mofetilo
oral
Otros nombres:
  • CelCept
  • Dos hombres y una mujer
Droga: alemtuzumab
Intravenous (IV)
Otros nombres:
  • Campamento
Droga: steroids
IV and/or oral
Comparador activo: Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
Droga: tacrolimus
oral
Otros nombres:
  • Prograf, FK506
Droga: micofenolato de mofetilo
oral
Otros nombres:
  • CelCept
  • Dos hombres y una mujer
Droga: steroids
IV and/or oral
Droga: rabbit anti-thymocyte globulin
IV
Otros nombres:
  • Timoglobulina
Experimental: Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
Droga: tacrolimus
oral
Otros nombres:
  • Prograf, FK506
Droga: micofenolato de mofetilo
oral
Otros nombres:
  • CelCept
  • Dos hombres y una mujer
Droga: alemtuzumab
Intravenous (IV)
Otros nombres:
  • Campamento
Droga: steroids
IV and/or oral
Comparador activo: Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
Droga: tacrolimus
oral
Otros nombres:
  • Prograf, FK506
Droga: micofenolato de mofetilo
oral
Otros nombres:
  • CelCept
  • Dos hombres y una mujer
Droga: steroids
IV and/or oral
Droga: basiliximab
IV
Otros nombres:
  • simulect

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
Periodo de tiempo: 6 months

A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).

Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Patient Incidence of BCAR
Periodo de tiempo: End of Study (36 months)

Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Efficacy Failure
Periodo de tiempo: End of Study (36 months)

Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Clinically Treated Acute Rejection
Periodo de tiempo: End of Study (36 months)

Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Time to First BCAR
Periodo de tiempo: End of Study (36 months)

Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Graft Survival at 12 Months
Periodo de tiempo: 12 months

Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.

Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
12 months
Overall Graft Survival
Periodo de tiempo: End of Study (36 months)

Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Patient Survival at 12 Months
Periodo de tiempo: 12 months

Patient survival is defined as not dead within 12 months after skin closure.

Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
12 months
Overall Patient Survival
Periodo de tiempo: End of Study (36 months)

Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
End of Study (36 months)
Renal Function Abnormalities Based on Creatinine Clearance
Periodo de tiempo: 1 month and End of Study (36 months)

Increases in creatinine clearance usually indicates an improvement.

Change in creatinine clearance from month 1 was calculated.

Change from 1 month is calculated by month 36 - month 1.
1 month and End of Study (36 months)
Renal Function Abnormalities Based on Serum Creatinine
Periodo de tiempo: 1 month and End of Study (36 months)

Decrease in serum creatinine usually indicates an improvement.

Change in creatinine clearance from month 1 was calculated.

Change from 1 month is calculated by month 36 - month 1.
1 month and End of Study (36 months)

Colaboradores e Investigadores

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

Patrocinador

Astellas Pharma Inc

Investigadores

  • Director de estudio: Central Contact, Astellas Pharma Global Development

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 mayo de 2005

Finalización primaria (Actual)

1 de marzo de 2009

Finalización del estudio (Actual)

1 de marzo de 2009

Fechas de registro del estudio

Enviado por primera vez

7 de junio de 2005

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2005

Publicado por primera vez (Estimar)

8 de junio de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de agosto de 2011

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

9 de agosto de 2011

Última verificación

1 de agosto de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20-04-003

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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