Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol
| Autor: | Abdul Hammad, Kathy Jayne, William G. Herrington, Iain C. Macdougall, Paul Harden, Sanjay Sinha, Murat Akyol, Peter J. Friend, Martin J Landray, Keith Rigg, C. G. Newstead, Chidambaram Nathan, Argiris Asderakis, David Lewis, Jonathan Emberson, Michael Lay, Nithya Krishnan, Paul Gibbs, James Neuberger, Adnan Sharif, Neil S. Sheerin, Carmelo Puliatti, Alex Baxter, Ravi Pararajasingam, Paramit Chowdhury, Sunil Bhandari, Peter A. Rowe, Colin Baigent, Christopher J.E. Watson, Richard Haynes, Marc Clancy, Gareth Jones |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Oncology
medicine.medical_specialty Clinical Trial Protocol Basiliximab medicine.medical_treatment Immunology Tacrolimus Kidney transplantation Maintenance therapy Chronic allograft nephropathy Internal medicine medicine Alemtuzumab Sirolimus Transplantation business.industry Campath Immunosuppression medicine.disease Surgery Calcineurin surgical procedures operative Randomized controlled trial business medicine.drug |
| Zdroj: | Transplantation Research |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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