Study of Everolimus in de Novo Renal Transplant Recipients
Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.
The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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MG
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Divinópolis, MG, Brasil, 35500-227
- Hospital São João de Deus/Fundação Geraldo Corrêa
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Ipatinga, MG, Brasil, 35160-158
- Hospital Márcio Cunha/Fundação São Francisco Xavier
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Juiz de Fora, MG, Brasil, 36036-330
- Fundação IMEPEN
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Montes Claros, MG, Brasil, 39400-103
- Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Renal transplant patients
- Age between 18 and 85 years
- Recipients of living or deceased donors
- Donor under the age of 85 years
- Panel Reactivity Antibodies (PRA) over or equal to 30%
- 4-5 months post-transplant
- CNI-based immunosuppressive regimen
- Stable graft function (creatinine lower than 2.0 mg/dl)
- No currently acute rejection
- Proteinuria lower than 800mg/d
- No laboratory or physical clinically significant signs presented for the last 2 months before screening.
Exclusion Criteria:
- Recipient of multiple organs
- Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis
- Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL)
- Patients with eGFR lower than 40 ml/min/1.73m2
- Evidence of acute rejection within 2 months before screening
- Thrombocytopenia (lower than 75,000/mm3)
- Neutropenia (lower than 1,500/mm3)
- Leukocytopenia (lower than 2500/mm3)
- Anemia (hemoglobin lower than 6.0g/dL)
- Severe liver disease (including transaminases or bilirubin equal or over 3 times normal)
- Proteinuria over 800mg/dL
- Systemic infection or pneumonia (active infection)
- Positive for Hepatitis B, Hepatitis C or HIV.
Plan de estudios
¿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 |
|---|---|
|
Sin intervención: Control
35 patients using Cyclosporin or Tacrolimus (C0=100-200/5-10ng/mL)+ Myfortic® 1440mg/dia + Steroids. Medications will be administered orally, twice a day |
|
|
Comparador activo: Intervention
35 randomized Patients Converted to Certican® (Everolimus C0=6-10 ng/mL) + Myfortic® 1440mg/day + Steroids. On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended. |
On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in estimated glomerular filtration rate (eGFR)
Periodo de tiempo: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
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The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC).
|
4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
graft acute rejection
Periodo de tiempo: 6 and 12 months after conversion
|
incidence of acute biopsy-proven rejection and clinical acute rejection (without biopsy), graft loss, death with a functioning graft, and loss of follow up at 6 and 12 months after conversion;
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6 and 12 months after conversion
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Laboratory results and clinical alterations
Periodo de tiempo: 3, 6 and 12 months after conversion
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analyzing the incidence of anemia, thrombocytopenia, leukopenia, gastrointestinal side effects, pneumonitis, oral ulcers, edema, proteinuria, and any other adverse events, as well as the need of drug withdrawal
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3, 6 and 12 months after conversion
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hélady S Pinheiro, MD, PhD, Fundação IMEPEN
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRAD001ABR22T
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