3C Study

• Research type

  Research Study

• Full title

  Open-label, randomised multicentre study of CAMPATH-1H versus basiliximab induction treatment and sirolimus versus tacrolimus maintenance treatment for the preservation of renal function in patients receiving kidney transplants

• IRAS ID

  1176

• Contact name

  Peter Friend

• Sponsor organisation

  Oxford Radcliffe Hospitals NHS Trust

• Eudract number

  2008-008553-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Kidney transplantation is the treatment of choice for people with kidney failure because it improves the quantity and quality of life of such patients. Although the short-term survival of kidney transplants has improved over the last decade, there has been no improvement in the long-term survival of kidney transplants. This is in part because some of the immunosuppressant medications - which are vital to prevent the body "rejecting" the transplanted kidney - damage the kidney in the long-term. In particular, a group of drugs called calcineurin inhibitors (CNIs) are known to cause kidney damage. The 3C study aims to test two strategies to reduce the requirement for CNIs. Firstly, giving powerful antibody-based treatments at the time of transplantation ("induction" treatment) can reduce the amount of other immunosuppression which is required. This might reduce the amount of damage done to the transplant by such drugs and therefore improve the long-term survival of the transplant. Campath is a powerful antibody which causes potent immunosuppression for many months. There is some data to suggest is safe and effective, but larger and longer trials are needed to establish this. It will be compared with standard antibody induction treatment in the 3C study. A second strategy is to use different immunosuppressive drugs in the long-term which are less likely to damage the transplant. Sirolimus is an effective immunosuppressant which early studies have shown can be effective in protecting the kidney from damage caused by CNIs. However, the best way to use sirolimus is not clear so further trials are required. Sirolimus will be compared with CNI-based treatment as long-term "maintenance" therapy in the 3C study.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/101

• Date of REC Opinion

  2 Dec 2009

• REC opinion

  Further Information Favourable Opinion