Conversion from Prograf to LCP-Tacro to prevent allograft rejection

• Research type

  Research Study

• Full title

  A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion from Prograf® Capsules Twice Daily to LCP-Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients

• IRAS ID

  10665

• Sponsor organisation

  LifeCycle Pharma A/S

• Eudract number

  2008-003240-11

• Clinicaltrials.gov Identifier

  00817206

• Research summary

  The purpose of this study is to compare the effectiveness and safety of an approved drug called Prograf to a new investigational drug called LCP-Tacro?½ when taken to prevent rejection of a transplanted kidney.There will be approximately 302 participants taking part in this study at about 50 transplant centres across North America and Europe. Approximately 30 participants will be taking part in the UK. The study is divided into an initial screening visit (to see if the participant's fully eligible to participate), a 7 day run-in period during which the participant will stay on their present Prograf medication and have the amount of tacrolimus (an immunosuppressive drug given to prevent rejection of the transplanted kidney) in their blood checked twice, and a 12 month treatment phase during which the participant will be randomly assigned (by chance like flipping a coin) to one of the following treatments:-1. to continue taking Prograf2. to switch to taking LCP-TacroAfter the first visit at the start of the 12 month treatment period, there are a total of 10 follow-up visits. The participant will be interviewed 30 days after leaving the study to see how they have been doing.A full assessment of the study results will be performed at the end of 12 months. An independent panel of experts will monitor the study progress and can recommend that the study be stopped early if there are any safety concerns.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/5

• Date of REC Opinion

  7 Jan 2009

• REC opinion

  Favourable Opinion