A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)
CompletadoFase 3ClinicalTrials.gov
ID: NCT01011205Tipo: INTERVENTIONALInicio: 30 de sept de 2009Fin estimado: 4 de ene de 2013
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
Elegibilidad
Edad mínima: 18 YearsSexo: ALL
Criterios de inclusión
Undergoing orthotopic liver or split liver allograft transplantation
Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Criterios de exclusión
Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
Receiving ABO incompatible graft or a graft from a non heart beating donor
Ongoing dosing with systemic corticosteroids
Subjects with systemic infection requiring treatment except viral hepatitis
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
\< 3 nodes
no node larger than 5 cm
no metastases
no vascular tumoral invasion
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Subject or donor known to be HIV positive
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Pregnant woman or breast-feeding mother
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Unlikely to comply with the Visits scheduled in the protocol
Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Intervenciones
drug
Advagraf
Capsule
drug
Mycophenolate Mofetil
Solution for infusion
drug
Basiliximab
IV infusion
drug
Corticosteroids
IV bolus
Ubicaciones
160
Buenos Aires, Argentina
Patrocinadores
PrincipalAstellas Pharma Inc
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