Phase II study to evaluate safety, tolerability and efficacy of OPN305

• Research type

  Research Study

• Full title

  A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

• IRAS ID

  118819

• Contact name

  Neil Sheerin

• Sponsor organisation

  Opsona Therapeutics Ltd

• Eudract number

  2012-001455-39

• ISRCTN Number

  N/A

• Research summary

  Renal graft function may be adequate or inadequate immediately following renal transplantation. Inadequate graft function consists of total non-function, slow graft function (SGF) or Delayed Graft Function (DGF). DGF is defined as a clinical complication following renal transplantation that requires renal dialysis within 7 days following transplantation. DGF is the most common kidney allograft complication in the immediate post-transplantation period affecting 25-35% of all patients who receive a cadaveric donor graft but rates over 60% have been reported especially in recipients of kidneys from extended criteria donors (ECD) and particularly from donors following circulatory death (DCD).This study will determine the effect of the addition of OPN305 to routine immunosuppression for the prevention of DGF (defined as the need for dialysis in the 7 days post-transplantation). A dialysis-based definition of DGF is considered to be the most accepted and appropriate primary endpoint for this Phase II study. Additionally, functional DGF (fDGF, defined as a failure to reduce serum creatinine by 10% per day during 3 successive days in the first 7 days following transplant surgery) will provide extra objective information and is ranked as the most important of the secondary endpoints of this study. This study will also investigate if the addition of OPN305 to a standard immunosuppressive regimen will help ensure adequate immunosuppression in the early post-transplant period.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  12/NE/0412

• Date of REC Opinion

  11 Feb 2013

• REC opinion

  Further Information Favourable Opinion