Bioavailability in stable patients after renal transplantation

• Research type

  Research Study

• Full title

  Comparative bioavailability of Myfenax® (Teva) and CellCept® (Roche) in stable patients after renal transplantation

• IRAS ID

  17973

• Contact name

  Richard Moore

• Sponsor organisation

  TEVA Pharmaceuticals Europe B.V.

• Eudract number

  2009-010562-31

• ISRCTN Number

  1

• Research summary

  Renal (kidney) transplantation is a life-extending procedure which becomes necessary when the fine particles of the kidney called nephrons loose their ability to filter harmful waste from the bodflud. This situation is called an end-stage renal disease.If a patient has received a kidney transplant, the body's immune system very often identifies the transplanted kidney as ??foreign? and rejects it. Therefore, those patients usually need to take a drug which suppresses the immune system??s response.Mycophenolate Mofetil is given to patients after a kidney transplant to prevent an unwanted immune response called acute rejection. TEVA would like to study a new formulation (Myfenax) compared with another marketed drug called CellCept© in patients who are stable 12 months after a kidney transplant. 100 male and female patients 18 years and older who have had a kidney transplant at least 12 months earlier and whose condition is considered stable will be invited to enter this international, multicentre study. The study will consist of a pre-study examination (screening), two treatment periods of two weeks each (periods I and II), and a follow-up treatment period of three months (period III). The total treatment duration in this study will be a maximum of 120 days.Patients will be randomised (chosen by chance) to initially receive either the test drug Myfenax© or the comparator drug CellCept©. The study has a ??crossover? design, meaning that patients will take one of the two treatments (either Myfenax© or CellCept©) in period I, and then switch to take the other one in period II. The same treatment as in period II is continued in period III.The sponsor wants to compare the two drugs Myfenax© and CellCept© to see how the body reacts to them and to confirm that their safety profiles are the same.

• REC name

  Wales REC 1

• REC reference

  09/WSE04/56

• Date of REC Opinion

  10 Dec 2009

• REC opinion

  Further Information Favourable Opinion