Immunosuppressive therapy for renal transplantation in adults.
2007/8/23
Brief Summary
GUIDELINE TITLE
Immunosuppressive therapy for renal transplantation in adults.
BIBLIOGRAPHIC SOURCE(S)
National Institute for Clinical Excellence (NICE). Immunosuppressive therapy for renal transplantation in adults. London (UK): National Institute for Clinical Excellence (NICE); 2004 Sep. 45 p. (Technology appraisal; no. 85).
GUIDELINE STATUS
This is the current release of the guideline.
BRIEF SUMMARY CONTENT
RECOMMENDATIONS
EVIDENCE SUPPORTING THE RECOMMENDATIONS
IDENTIFYING INFORMATION AND AVAILABILITY
DISCLAIMER
Go to the Complete Summary
RECOMMENDATIONS
MAJOR RECOMMENDATIONS
Basiliximab or daclizumab, used as part of a calcineurin-inhibitor-based immunosuppressive regimen, are recommended as options for induction therapy in the prophylaxis of acute organ rejection in adults undergoing renal transplantation. The induction therapy (basiliximab or daclizumab) with the lowest acquisition cost should be used.
Tacrolimus is an alternative to ciclosporin when a calcineurin inhibitor is indicated as part of an initial or a maintenance immunosuppressive regimen in renal transplantation for adults. The initial choice of tacrolimus or ciclosporin should be based on the relative importance of their side-effect profiles for individual people.
Mycophenolate mofetil is recommended for adults as an option as part of an immunosuppressive regimen only:
Where there is proven intolerance to calcineurin inhibitors, particularly nephrotoxicity leading to risk of chronic allograft dysfunction, or
In situations where there is a very high risk of nephrotoxicity necessitating minimisation or avoidance of a calcineurin inhibitor.
Sirolimus is recommended for adults as an option as part of an immunosuppressive regimen only in cases of proven intolerance to calcineurin inhibitors (including nephrotoxicity) necessitating complete withdrawal of these treatments.
These recommendations contain advice that may result in some medicines being prescribed outside the terms of their marketing authorisation. Clinicians prescribing these drugs should ensure that patients are aware of this, and that they consent to their use in such circumstances.
CLINICAL ALGORITHM(S)
None provided
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EVIDENCE SUPPORTING THE RECOMMENDATIONS
TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS
The type of evidence supporting the recommendations is not specifically stated.
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IDENTIFYING INFORMATION AND AVAILABILITY
BIBLIOGRAPHIC SOURCE(S)
National Institute for Clinical Excellence (NICE). Immunosuppressive therapy for renal transplantation in adults. London (UK): National Institute for Clinical Excellence (NICE); 2004 Sep. 45 p. (Technology appraisal; no. 85).
ADAPTATION
Not applicable: The guideline was not adapted from another source.
DATE RELEASED
2004 Aug
GUIDELINE DEVELOPER(S)
National Institute for Health and Clinical Excellence - National Government Agency [Non-U.S.]
SOURCE(S) OF FUNDING
National Institute for Health and Clinical Excellence (NICE)
GUIDELINE COMMITTEE
Appraisal Committee
COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE
Dr Jane Adam, Radiologist, St George’s Hospital, London; Dr Sunil Angris, General Practitioner, Waterhouses Medical Practice, Staffordshire; Dr Darren Ashcroft, Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical Sciences, University of Manchester; Professor David Barnett (Vice Chair), Professor of Clinical Pharmacology, University of Leicester; Dr Peter Barry, Consultant in Paediatric Intensive Care and Honorary Senior Lecturer, Department of Child Health, Leicester Royal Infirmary; Professor John Brazier, Health Economist, University of Sheffield; Professor John Cairns, Professor of Health Economics, Health Economics Research Unit, University of Aberdeen; Professor Mike Campbell, Statistician, Institute of General Practice & Primary Care, Sheffield; Dr Peter I Clark, Consultant Medical Oncologist, Clatterbridge Centre for Oncology, Wirral, Merseyside; Dr Mike Davies, Consultant Physician, University Department of Medicine & Metabolism, Manchester Royal Infirmary; Mr Richard Devereaux-Phillips, Public Affairs Manager, Medtronic Ltd; Professor Cam Donaldson, PPP Foundation Professor of Health Economics, School of Population and Health Sciences & Business School, Business School - Economics, University of Newcastle upon Tyne; Professor Jack Dowie, Health Economist, London School of Hygiene; Dr Paul Ewings, Statistician, Taunton & Somerset NHS Trust, Taunton; Professor Terry Feest, Clinical Director and Consultant Nephrologist, Richard Bright Renal Unit; Chair of UK Renal Registry, Bristol; Ms Sally Gooch, Director of Nursing, Mid-Essex Hospital Services NHS Trust, Chelmsford; Professor Trisha Greenhalgh, Professor of Primary Health Care, University College London; Miss Linda Hands, Clinical Reader in Surgery, University of Oxford; Professor Peter Jones, Professor of Statistics and Dean, Faculty of Natural Sciences, Keele University; Professor Robert Kerwin, Professor of Psychiatry and Clinical Pharmacology, Institute of Psychiatry, London; Ms Joy Leavesley, Senior Clinical Governance Manager, Guy’s and St Thomas’ NHS Trust; Ms Ruth Lesirge, Lay Representative, previously Director, Mental Health Foundation, London; Dr George Levvy, Lay Representative, Chief Executive, Motor Neurone Disease Association, Northampton; Ms Rachel Lewis, Staff Nurse (Nephrology) Hull Royal Infirmary; Dr Rubin Minhas, General Practitioner with a Special Interest in Coronary Heart Disease, Primary Care CHD Lead, Medway PCT and Swale PCT; Dr Gill Morgan, Chief Executive, NHS Confederation, London; Professor Philip Routledge, Professor of Clinical Pharmacology, College of Medicine, University of Wales, Cardiff; Dr Stephen Saltissi, Consultant Cardiologist, Royal Liverpool University Hospital; Mr Miles Scott, Chief Executive, Harrogate Health Care NHS Trust; Professor Andrew Stevens (Vice-Chair), Professor of Public Health, University of Birmingham; Professor Mary Watkins, Professor of Nursing, University of Plymouth; Dr Norman Waugh, Department of Public Health, University of Aberdeen
FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST
Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.
GUIDELINE STATUS
This is the current release of the guideline.
GUIDELINE AVAILABILITY
Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.
Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. 11 Strand, London, WC2N 5HR.
AVAILABILITY OF COMPANION DOCUMENTS
The following are available:
Immunosuppressive therapy for renal transplantation in adults Quick reference guide. London (UK): National Institute for Health and Clinical Excellence (NICE); 2004 Sep. 2 p. (Technology appraisal 85). Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site.
Clinical and cost-effectiveness of immunosuppressive regimens in renal transplantation. Assessment report. Birmingham (UK): West Midlands Health Technology Assessment Group; 2002 Dec. 258 p. (Technology appraisal 85). Electronic copies: Available in PDF from the National Institute for Health and Clinical Excellence (NICE) Web site.
Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. 11 Strand, London, WC2N 5HR.
Additionally, Audit Criteria can be found in Appendix C of the original guideline document.
PATIENT RESOURCES
The following is available:
Drugs to prevent the rejection of kidney transplants in adults: understanding NICE guidance - information for people undergoing kidney transplants, their families and carers, and the public. London: National Institute for Health and Clinical Excellence. 2004 Sep. 10 p. Available in English and Welsh in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.
Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline’s content.
NGC STATUS
This NGC summary was completed by ECRI on November 10, 2005.
The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their Technology Appraisal guidance with the intention of disseminating and facilitating the implementation of that guidance. NICE has not verified this content to confirm that it accurately reflects the original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE technology appraisal guidance is prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.
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