title: Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol.
abstract: BACKGROUND
  Kidney transplantation is the best treatment for patients with end-stage renal failure, but uncertainty remains about the best immunosuppression strategy. Long-term graft survival has not improved substantially, and one possible explanation is calcineurin inhibitor (CNI) nephrotoxicity. CNI exposure could be minimized by using more potent induction therapy or alternative maintenance therapy to remove CNIs completely. However, the safety and efficacy of such strategies are unknown.
  
  
  METHODS
  The Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy (3C) Study is a multicentre, open-label, randomized controlled trial with 852 participants which is addressing two important questions in kidney transplantation. The first question is whether a Campath (alemtuzumab)-based induction therapy strategy is superior to basiliximab-based therapy, and the second is whether, from 6 months after transplantation, a sirolimus-based maintenance therapy strategy is superior to tacrolimus-based therapy. Recruitment is complete, and follow-up will continue for around 5 years post-transplant. The primary endpoint for the induction therapy comparison is biopsy-proven acute rejection by 6 months, and the primary endpoint for the maintenance therapy comparison is change in estimated glomerular filtration rate from baseline to 2 years after transplantation. The study is sponsored by the University of Oxford and endorsed by the British Transplantation Society, and 18 centers for adult kidney transplant are participating.
  
  
  CONCLUSIONS
  Late graft failure is a major issue for kidney-transplant recipients. If our hypothesis that minimizing CNI exposure with Campath-based induction therapy and/or an elective conversion to sirolimus-based maintenance therapy can improve long-term graft function and survival is correct, then patients should experience better graft function for longer. A positive outcome could change clinical practice in kidney transplantation.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01120028 and ISRCTN88894088.
authors: Clinical Trial Service Unit & Epidemiological Studies Unit, Richard Doll Building, Old Road Campus, Roosevelt Drive, Headington Oxford OX3 7LF, UK. richard.haynes@ctsu.ox.ac.uk.
authors: Richard
authors: R
authors: Haynes
authors: Colin
authors: C
authors: Baigent
authors: Paul
authors: P
authors: Harden
authors: Martin
authors: M
authors: Landray
authors: Murat
authors: M
authors: Akyol
authors: Argiris
authors: A
authors: Asderakis
authors: Alex
authors: A
authors: Baxter
authors: Sunil
authors: S
authors: Bhandari
authors: Paramit
authors: P
authors: Chowdhury
authors: Marc
authors: M
authors: Clancy
authors: Jonathan
authors: J
authors: Emberson
authors: Paul
authors: P
authors: Gibbs
authors: Abdul
authors: A
authors: Hammad
authors: Will
authors: W
authors: Herrington
authors: Kathy
authors: K
authors: Jayne
authors: Gareth
authors: G
authors: Jones
authors: Nithya
authors: N
authors: Krishnan
authors: Michael
authors: M
authors: Lay
authors: David
authors: D
authors: Lewis
authors: Iain
authors: I
authors: Macdougall
authors: Chidambaram
authors: C
authors: Nathan
authors: James
authors: J
authors: Neuberger
authors: Chas
authors: C
authors: Newstead
authors: Ravi
authors: R
authors: Pararajasingam
authors: Carmelo
authors: C
authors: Puliatti
authors: Keith
authors: K
authors: Rigg
authors: Peter
authors: P
authors: Rowe
authors: Adnan
authors: A
authors: Sharif
authors: Neil
authors: N
authors: Sheerin
authors: Sanjay
authors: S
authors: Sinha
authors: Chris
authors: C
authors: Watson
authors: Peter
authors: P
authors: Friend
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