CAEB071A2214

• Research type

  Research Study

• Full title

  A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients

• IRAS ID

  37994

• Contact name

  Marius Scholtz

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-015456-14

• ISRCTN Number

  Not available

• Research summary

  The purpose of this study is to build upon the experience gained from previous studies and to investigate the efficacy and safety of a new drug Sotrastaurin in combination with tacrolimus in renal transplant patients. This study is an international 36 month, partially blinded, multi-center study that aims to enrol 300 participants. 5 UK centres will take part and contribute about 20 patients. Following informed consent, and a successful transplant operation, participants will be randomly allocated to one of four treatment groups. sotrastaurin 100 mg twice a day + standard dose tacrolimusâ„¢ sotrastaurin 200 mg twice a day + standard dose tacrolimusâ„¢ sotrastaurin 300 mg twice a day + reduced dose tacrolimusâ„¢ control arm: myfortic 720 mg twice a day + standard dose tacrolimus. There will be a total of 21 study visits over the three year period most of which will occur during routine follow up visits. At each study visit the participants will have blood and urine samples taken for safety checks such as blood chemistry, haematology and viral screening. The amount of study drug in the blood will also be measured. An ECG will be performed at most visits. The objective is to compare the rate of primary efficacy failure (acute rejection, graft loss or death) in each of the groups at 6 months. Renal function, safety, tolerability and efficacy of all the treatments will be documented throughout the study. Any patient who experiences acute rejection of their transplanted organ (as confirmed by a biopsy) will be transferred to a treatment regimen of the transplanting centres choice. They will continue to be followed up within the trial. The study will enable a comparative assessment of the safety, efficacy and tolerability of sotrastaurin in recipients of renal transplants. This study is being organised by Novartis Pharma Services AG, CH 4056, Basel , Switzerland

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/126

• Date of REC Opinion

  10 Dec 2009

• REC opinion

  Favourable Opinion