Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney Transplantation in Vivo
Renal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function.
Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Objective: Evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation.
Material and methods: Controlled, double-blind clinical trial with posterior following for 12 months. Composed by 48 patients, randomized manner, realized at the Transplant Department of Western Medical Center, Mexican Institute of Social Security. Universe was patients accepted as kidney donors. Patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. Previous surgical procedure, in a blood sample, C-Reactive Protein (C-RP) and laboratory control were measured. During surgical procedure, a biopsy was obtained to measure IL-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. During surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of Banff
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Jalisco
-
Guadalajara, Jalisco, México, 44340
- Western Medical Center, Mexican Institute of Social Security
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Accepted as kidney donor
- Voluntary participation
- Informed consent accepted
- 85% fulfillment of atorvastatin treatment
Exclusion Criteria:
- Hypersensibility to Atorvastatin
- Smoking
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Atorvastatin
22 patients received oral atorvastatin 40 mg 1 time for day for 4 weeks
|
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation.
Previous surgical procedure controls were performed
Otros nombres:
|
|
Comparador de placebos: Placebo
22 patients received oral placebo 40 mg 1 time for day for 4 weeks
|
Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation.
Previous surgical procedure were performed
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
C-Reactive Protein evolution in donors
Periodo de tiempo: Basal and 4 weeks later
|
C-Reactive Protein was measured when patients (donors) were accepted in the study and 4 weeks later.
The last blood sample was taken the day of surgical procedure.
|
Basal and 4 weeks later
|
|
Kidney graft rejection using scale of BANFF
Periodo de tiempo: Basal, 3 months and 12 months
|
During surgical procedure and before organ transplantation, basal biopsy was obtain.
In the following at 3 and 12 months after kidney transplantation, were performed the other two biopsy.
Alterations between groups were registered.
|
Basal, 3 months and 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Kidney function evolution after transplant
Periodo de tiempo: 24 hours, 3 months and 12 months
|
In blood samples, after kidney transplantation, creatinine and urea were measured.
Differences in evolution and alteration between the 2 groups were registered
|
24 hours, 3 months and 12 months
|
|
Interleukin and tumor necrosis factor alpha.
Periodo de tiempo: Basal
|
During surgical procedure and before organ transplantation, the biopsy was obtain to measure interleukin 6 and tumor necrosis factor alpha, observing alteration between groups.
|
Basal
|
|
Complications
Periodo de tiempo: 24 hours, 3 months and 12 months
|
During surgical procedure, any kind of complication was registered, the same right after surgery and in the following.
|
24 hours, 3 months and 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Clotilde Fuentes-Orozco, PhD, Instituto Mexicano del Seguro Social
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
- Enfermedades Renales
- Enfermedades urológicas
- Insuficiencia renal
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos
- Agentes Anticolesterolémicos
- Agentes hipolipidémicos
- Agentes reguladores de lípidos
- Inhibidores de la hidroximetilglutaril-CoA reductasa
- Atorvastatina
Otros números de identificación del estudio
- 2011-1301-78
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. .