A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)

CompletadoFase 4ClinicalTrials.gov

ID: NCT00717470Tipo: INTERVENTIONALInicio: 14 de may de 2008Fin estimado: 2 de mar de 2010

Traducción no disponible, mostrando original

Resumen

To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study

Criterios de exclusión

Receiving or having previously received an organ transplant other than a kidney
Cold ischemia time of the donor kidney \> 30 hours
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Pregnant woman or breast-feeding mother
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
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
Currently participating in another clinical trial, and/or has taken an investigational drug 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

Prograf®

oral

drug

Advagraf®

oral

drug

Mycophenolate Mofetil

oral

drug

Simulect

oral

drug

methylprednisolone / prednisone

oral

Ubicaciones

Buenos Aires, Argentina

Córdoba, Argentina

Patrocinadores

PrincipalAstellas Pharma Inc

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