Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
19 de julho de 2013 atualizado 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.
Visão geral do estudo
Status
Rescindido
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
72
Estágio
- Fase 3
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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Alberta
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Calgary, Alberta, Canadá, T2N 2T9
- Pfizer Investigational Site
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Edmonton, Alberta, Canadá, T6G 2B7
- Pfizer Investigational Site
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Ontario
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Hamilton, Ontario, Canadá, L8N 4A6
- Pfizer Investigational Site
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London, Ontario, Canadá, N6A 5A5
- Pfizer Investigational Site
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Toronto, Ontario, Canadá, M5C 2T2
- Pfizer Investigational Site
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Toronto, Ontario, Canadá, M5B 1W8
- Pfizer Investigational Site
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Pfizer Investigational Site
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New York
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Rochester, New York, Estados Unidos, 14642
- Pfizer Investigational Site
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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
35 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 1
Tacrolimus + MMF + Steroids
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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.
Outros nomes:
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.
Outros nomes:
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.
Outros nomes:
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.
Outros nomes:
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Experimental: 2
Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
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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.
Outros nomes:
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.
Outros nomes:
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.
Outros nomes:
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.
Outros nomes:
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
Prazo: Pre-conversion baseline and 12 months post-transplant
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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.
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Pre-conversion baseline and 12 months post-transplant
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TPV at Pre-conversion Baseline
Prazo: Pre-conversion baseline
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TPV is the sum of the assessment in left and right distal common carotid arteries.
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Pre-conversion baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant
Prazo: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
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CIMT at Pre-conversion Baseline
Prazo: Pre-conversion baseline
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Mean CIMT=average of left CIMT and right CIMT.
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Pre-conversion baseline
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Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant
Prazo: Pre-conversion baseline, 12, and 24 months post-transplant
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Carotid plaque roughness as determined by ultrasound.
Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.
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Pre-conversion baseline, 12, and 24 months post-transplant
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Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant
Prazo: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Fasting plasma glucose.
Change = value at month x post-transplant - pre-conversion baseline values.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Fasting insulin.
Change = value at month x post-transplant - pre-conversion baseline.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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HbA1C, change = value at month x post-transplant - pre-conversion baseline.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant
Prazo: 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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant
Prazo: Pre-conversion baseline, 12, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, 12, 24 and 36 months post-transplant
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Number of Participants Who Used Lipid Lowering Therapies
Prazo: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
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Participants who reported "yes" for taking lipid lowering therapies as concomitant medication.
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From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
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Number of Participants Who Used Anti-hypertensive Medications
Prazo: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
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Participants who reported "yes" for taking anti-hypertensive medications as concomitant medication.
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From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
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Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant
Prazo: Pre-conversion baseline, and 18, 24 and 36 months post-transplant
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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.
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Pre-conversion baseline, and 18, 24 and 36 months post-transplant
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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 abril de 2006
Conclusão Primária (Real)
1 de dezembro de 2010
Conclusão do estudo (Real)
1 de janeiro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
3 de abril de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de abril de 2006
Primeira postagem (Estimativa)
5 de abril de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
23 de setembro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de julho de 2013
Última verificação
1 de julho de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Doenças Vasculares
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doenças renais
- Doenças Urológicas
- Insuficiência renal
- Doenças da Artéria Carótida
- Aterosclerose
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Inibidores Enzimáticos
- Antiinflamatórios
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Agentes antibacterianos
- Antibióticos, Antineoplásicos
- Antifúngicos
- Agentes Antituberculares
- Antibióticos, Antituberculose
- Inibidores de Calcineurina
- Prednisona
- Tacrolimo
- Ácido micofenólico
- Sirolimo
Outros números de identificação do estudo
- 0468H1-319
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 .