Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol
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- 作者：Richard Haynes (1)
Colin Baigent (1)
Paul Harden (2)
Martin Landray (1)
Murat Akyol (3)
Argiris Asderakis (4)
Alex Baxter (1)
Sunil Bhandari (5)
Paramit Chowdhury (6)
Marc Clancy (7)
Jonathan Emberson (1)
Paul Gibbs (8)
Abdul Hammad (9)
Will Herrington (1)
Kathy Jayne (1)
Gareth Jones (10)
Nithya Krishnan (11)
Michael Lay (1)
David Lewis (1)
Iain Macdougall (12)
Chidambaram Nathan (13)
James Neuberger (14)
Chas Newstead (15)
Ravi Pararajasingam (16)
Carmelo Puliatti (17)
Keith Rigg (18)
Peter Rowe (19)
Adnan Sharif (20)
Neil Sheerin (21)
Sanjay Sinha (22)
Chris Watson (23)
Peter Friend (24) - 关键词：Kidney transplantation ; Alemtuzumab ; Campath ; Sirolimus ; Randomized controlled trial ; Basiliximab ; Tacrolimus
- 刊名：Transplantation Research
- 出版年：2013
- 出版时间：December 2013
- 年：2013
- 卷：2
- 期：1
- 全文大小：359KB
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Colin Baigent (1)
Paul Harden (2)
Martin Landray (1)
Murat Akyol (3)
Argiris Asderakis (4)
Alex Baxter (1)
Sunil Bhandari (5)
Paramit Chowdhury (6)
Marc Clancy (7)
Jonathan Emberson (1)
Paul Gibbs (8)
Abdul Hammad (9)
Will Herrington (1)
Kathy Jayne (1)
Gareth Jones (10)
Nithya Krishnan (11)
Michael Lay (1)
David Lewis (1)
Iain Macdougall (12)
Chidambaram Nathan (13)
James Neuberger (14)
Chas Newstead (15)
Ravi Pararajasingam (16)
Carmelo Puliatti (17)
Keith Rigg (18)
Peter Rowe (19)
Adnan Sharif (20)
Neil Sheerin (21)
Sanjay Sinha (22)
Chris Watson (23)
Peter Friend (24)
1. Clinical Trial Service Unit & Epidemiological Studies Unit, Richard Doll Building, Old Road Campus, Roosevelt Drive, Headington Oxford, OX3 7LF, UK
2. Oxford Kidney Unit, Churchill Hospital, Headington, Oxford, OX3 7LJ, UK
3. Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK
4. University Hospital of Wales, Heath Park, Cardiff, CF4 4XW, UK
5. Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK
6. Guy鈥檚 Hospital, St Thomas Street, London, SE1 9RT, UK
7. Western Infirmary, Dumbarton Road, Glasgow, G11 6NT, UK
8. Queen Alexandra Hospital, Cosham, Portsmouth, PO6 3LY, UK
9. Royal Liverpool University Hospital, Prescot Street, Liverpool, L7 8XN, UK
10. Royal Free Hospital, Pond Street, London, NW3 2QG, UK
11. University Hospitals Coventry and Warwickshire NHS Trust, Clifford Bridge Road, Coventry, West Midlands, CV2 2DX, UK
12. King鈥檚 College Hospital, Denmark Hill, London, SE5 9RS, UK
13. Northern General Hospital, Herries Road, Sheffield, S5 7HU, UK
14. NHS Blood and Transplant, Stoke Gifford, Bristol, BS34 8RR, UK
15. St James鈥檚 University Hospital, Beckett Street, Leeds, LS9 7TF, UK
16. Manchester Royal Infirmary, Oxford, Manchester, M13 9WL, UK
17. Royal London Hospital, Whitechapel, London, E1 1BB, UK
18. City Hospital, Hucknall Road, Nottingham, NG5 1PB, UK
19. Derriford Hospital, Derriford Road, Plymouth, PL6 8DH, UK
20. Queen Elizabeth Hospital, Edgbaston, Birmingham, West Midlands, B15 2TH, UK
21. Freeman Hospital, High Heaton, Newcastle-upon-Tyne, NE7 7DN, UK
22. Oxford Transplant Centre, Churchill Hospital, Headington, Oxford, OX3 7LJ, UK
23. Addenbrooke鈥檚 Hospital, Cambridge, CB\2 2QQ, UK
24. Churchill Hospital, Headington, Oxford, OX3 7LJ, UK
文摘
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/Design 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT01120028 and ISRCTN88894088