Advagraf, Mycophenolate Mofetil & Basiliximab in Liver Transplant.

• Research type

  Research Study

• Full title

  A multicentre, three arm, randomised, 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).

• IRAS ID

  15192

• Contact name

  A David Mayer

• Sponsor organisation

  Astellas Pharma Europe Ltd.

• Eudract number

  2008-002231-32

• ISRCTN Number

  N/A

• Research summary

  Patients undergoing organ transplantation are required to take medication to suppress their immune system in order to prevent rejection of the new organ. This medication has to be taken indefinitely. Combinations of immunosuppressive drugs are normally taken. One of the key drugs prescribed is tacrolimus and a once daily formulation of tacrolimus Advagraf has been developed. Tacrolimus in combination with steroids together with an agent called mycophenolate mofetil (MMF) is the standard treatment. One of the most commonly used immunosuppressive drugs in liver transplantation is Tacrolimus, which is usually used in combination with steroids and other agents such as mycophenolate mofetil (MMF) and/or antibodies (such as Basiliximab). Tacrolimus can be used as a once a day preparation called Advagraf. Basiliximab has the potential to improve renal function by allowing a delay in the start of tacrolimus introduction. Renal failure may develop late after liver transplantation and is a significant cause of morbidity and mortality in these patients. There are a number of causes of renal failure post liver transplantation but one of the strongest predictive factors is the dose and level of tacrolimus in the early post transplantation period. This study has been designed to determine whether delayed administration of Advagraf in the immediate period post liver transplantation and lowered Advagraf exposure may prevent subsequent renal function deterioration. The primary aim of this study is to compare three therapy regimens with regard to renal function. The three treatment arms are: Arm 1: Advagraf (standard dose) MMF Corticosteroids (Single Bolus) Arm 2: Advagraf (low dose) MMF Basiliximab Corticosteroids (Single Bolus) Arm 3: Advagraf (5 days delay) MMF Basiliximab Corticosteroids (Single Bolus)

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  09/H0301/42

• Date of REC Opinion

  27 Aug 2009

• REC opinion

  Further Information Favourable Opinion