Randomized trial of rituximab in renal transplantation

• Research type

  Research Study

• Full title

  A randomized trial of Rituximab in induction therapy for living donor renal transplantation

• IRAS ID

  34035

• Contact name

  Nizam Mamode

• Sponsor organisation

  (GSTFT) Guy's and St Thomas NHS Foundation Trust

• Eudract number

  2009-017066-23

• Research summary

  In recent years, long term graft survival has been unchanged in kidney transplant recipients. This is partly due to drug toxicity and partly due to immunological reactions against the graft. The aim of this study is twofold; firstly to determine whether a new drug, rituximab, can allow us to minimise the immunosuppressive(antirejection) drugs and therefore prolong graft survival (as well as minimising side effects), and secondly to work out whether the T cell response, a fundamental part of the rejection process, can be affected by rituximab.
  Rituximab has recently been shown to result in low rejection rates when given as a single pre-operative dose in renal transplantation. We aim to use it to minimise immunosuppressive drugs, by avoiding steroids and reducing the dose of tacrolimus, which should result in better long term graft survival, fewer complications and lower costs when compared with existing regimens. Rituximab works by depleting B cells, which produce antibodies and form an important part of the immune system. However, although Rituximab appears to reduce rejection, the T cell has previously been thought to be the most important cell in acute rejection. It is unclear whether B cell depletion helps directly, or by preventing specific T cell responses. We will therefore study T cell function in these patients, to attempt to determine for the first time whether these are affected by B Cell depletion. Should this be the case, this would have profound implications for the way we approach immunosuppression in transplant patients.
  Patients undergoing transplantation will be randomized to one of two immunosuppressive regimens: 1) basiliximab (an induction agent), low dose tacrolimus, mycophenylate and steroids or 2) rituximab (in a single dose), basiliximab, low dose tacrolimus and mycophenylate. Outcome measures will be kidney function at one year (GFR) and rejection episodes. We will also measure the response of T cells directed against the donor and study the T cell repertoire.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/110

• Date of REC Opinion

  25 Jan 2010

• REC opinion

  Further Information Favourable Opinion