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Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

19 de julio de 2013 actualizado por: Pfizer

A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients

The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18. All sites were asked to have patients returned to the sites and have all end of study procedures performed by Dec 31, 2011.

The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint. The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being.

Tipo de estudio

Intervencionista

Inscripción (Actual)

72

Fase

  • Fase 3

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

  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 2T9
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canadá, T6G 2B7
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 4A6
        • Pfizer Investigational Site
      • London, Ontario, Canadá, N6A 5A5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canadá, M5C 2T2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canadá, M5B 1W8
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canadá, H1T 2M4
        • Pfizer Investigational Site
  • Estados Unidos
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • 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

35 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

At least one of the following characteristics:

  • History of dialysis for at least 3 years.
  • History of diabetes for at least 5 years.
  • Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss of the first transplant.
  • History of coronary artery disease, stroke, myocardial infarction, or amputation for vascular disease.

Exclusion Criteria:

  • History of malignancy within the last 5 years (except adequately treated skin cancer).
  • Recipients of non-renal organ transplant.
  • Active gastrointestinal disease that may interfere with drug absorption.
  • Active HIV, hepatitis B or C infection.
  • Women who are pregnant or breastfeeding.

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
Comparador activo: 1
Tacrolimus + MMF + Steroids
Droga: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
Otros nombres:
  • CNI
Droga: mycophenolate mofetil
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
Otros nombres:
  • MMF, MPS
Droga: prednisone
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
Otros nombres:
  • CCS
Droga: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. Reintroduction of TAC or introduction of CsA is not permitted in the SRL Therapy group.
Otros nombres:
  • CNI
Experimental: 2
Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
Droga: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
Otros nombres:
  • CNI
Droga: mycophenolate mofetil
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
Otros nombres:
  • MMF, MPS
Droga: prednisone
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
Otros nombres:
  • CCS
Droga: tacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. Reintroduction of TAC or introduction of CsA is not permitted in the SRL Therapy group.
Otros nombres:
  • CNI
Droga: sirolimus

The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol.

On study Day 1 Conversion, the daily dose of TAC will not be taken, and SRL is initiated as a single 5-10 mg loading dose, followed by 3 mg/day on subsequent days, adjusted to maintain a SRL target trough level of 8-15 ng/mL through to month 24 post-transplant, then 5-12 ng/mL to the end of month 36 post-transplant.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
Periodo de tiempo: Pre-conversion baseline and 12 months post-transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Pre-conversion baseline and 12 months post-transplant
TPV at Pre-conversion Baseline
Periodo de tiempo: Pre-conversion baseline
TPV is the sum of the assessment in left and right distal common carotid arteries.
Pre-conversion baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant
Periodo de tiempo: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years.
Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
CIMT at Pre-conversion Baseline
Periodo de tiempo: Pre-conversion baseline
Mean CIMT=average of left CIMT and right CIMT.
Pre-conversion baseline
Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, and 24 months post-transplant
Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.
Pre-conversion baseline, 12, and 24 months post-transplant
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant
Periodo de tiempo: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.
Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
HbA1C, change = value at month x post-transplant - pre-conversion baseline.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant
Periodo de tiempo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Pre-conversion baseline, 12, 24 and 36 months post-transplant
Number of Participants Who Used Lipid Lowering Therapies
Periodo de tiempo: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Participants who reported "yes" for taking lipid lowering therapies as concomitant medication.
From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Number of Participants Who Used Anti-hypertensive Medications
Periodo de tiempo: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Participants who reported "yes" for taking anti-hypertensive medications as concomitant medication.
From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant
Periodo de tiempo: Pre-conversion baseline, and 18, 24 and 36 months post-transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Pre-conversion baseline, and 18, 24 and 36 months post-transplant

Colaboradores e Investigadores

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

Patrocinador

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.

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 abril de 2006

Finalización primaria (Actual)

1 de diciembre de 2010

Finalización del estudio (Actual)

1 de enero de 2012

Fechas de registro del estudio

Enviado por primera vez

3 de abril de 2006

Primero enviado que cumplió con los criterios de control de calidad

3 de abril de 2006

Publicado por primera vez (Estimar)

5 de abril de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

23 de septiembre de 2013

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

19 de julio de 2013

Última verificación

1 de julio de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0468H1-319

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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