PK Comparison of Prograf and Advagraf in adults: Version 1

• Research type

  Research Study

• Full title

  A Phase II, Open Label, Parallel Group, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up.

• IRAS ID

  72367

• Contact name

  Nizar Abraham Ahad Yonan

• Sponsor organisation

  Astellas Pharma Ltd.

• Eudract number

  2010-019859-21

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Tacrolimus is a drug, which prevents organ rejection following an organ transplant. There are currently a number of formulations of tacrolimus on the market. Prograf© is a twice daily formulation of tacrolimus and Advagraf© is a once daily formulation both of which are capsules taken by mouth. Prograf© has received marketing approval for the prevention of organ rejection in adult and paediatric heart, liver and kidney transplants, however it is not currently approved for the prevention of pancreas or lung transplants. Advagraf© has received marketing approval for the prevention of organ rejection in both adult kidney and liver transplants however it is not currently approved for the prevention of heart, lung, pancreas and simultaneous pancreas kidney (SPK) transplant rejection. Subjects will be told about the study before they have their organ transplantation and provided they are willing to take part and meet the inclusion/exclusion criteria they will be enrolled into the study. The study is divided into two parts. Part A will compare the Pharmacokinetic data (the way the body absorbs, distributes, metabolizes and breaks down the drug) of Advagraf© against Prograf© and Part B will assess how safe and effective Advagraf© is over Prograf© between adults patients who are receiving an organ transplant. This means that patients will be allocated to either Prograf© or Advagraf© treatment. Patients will remain on their allocated medication for the duration of the study and should not switch to the alternative treatment. To measure the safety and efficiency of Advagraf© and Prograf© patients will be followed up for one year following completion of the blood sampling. The information obtained in conclusion of the study may give doctors further guidance in treating adult transplant patients.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  11/EE/0093

• Date of REC Opinion

  19 May 2011

• REC opinion

  Further Information Favourable Opinion