Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
NCT ID: NCT01120028
Last Updated: 2020-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
852 participants
INTERVENTIONAL
2010-09-30
2020-03-31
Brief Summary
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Detailed Description
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Two possible strategies to do this were tested. Firstly, Campath-1H (a monoclonal lymphocyte-depleting antibody) was compared to standard basiliximab-based induction. All patients then received tacrolimus-based maintenance therapy for 6-months (using lower doses in the Campath-1H arm).
At six months, patients were re-randomized between remaining on tacrolimus and converting to sirolimus (and therefore no longer taking calcineurin inhibitors). Patients were then followed-up in clinic and through routine NHS registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Alemtuzumab/Sirolimus
Induction therapy allocation: Alemtuzumab (Campath-1H).
Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
Alemtuzumab
Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart
Sirolimus
Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL
Alemtuzumab/Tacrolimus
Induction therapy allocation: Alemtuzumab (Campath-1H).
Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
Alemtuzumab
Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart
Tacrolimus
Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization.
Basiliximab/Tacrolimus
Induction therapy allocation: Basiliximab.
Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
Basiliximab
20 mg intravenously, two doses 96 hours apart
Tacrolimus
Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization.
Basiliximab/Sirolimus
Induction therapy allocation: Basiliximab.
Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
Basiliximab
20 mg intravenously, two doses 96 hours apart
Sirolimus
Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL
Interventions
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Alemtuzumab
Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart
Basiliximab
20 mg intravenously, two doses 96 hours apart
Sirolimus
Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL
Tacrolimus
Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* recipient of kidney transplant (planned in next 24 hours)
Exclusion Criteria
* previous treatment with Campath-1H
* active infection (including HIV, hepatitis B or C)
* history of anaphylaxis to humanized monoclonal antibody
* history of malignancy (except adequately treated non-melanoma skin cancer)
* loss of kidney transplant within 6 months not due to technical reasons
* medical history that might limit the individual's ability to take trial treatments for the duration of the study
18 Years
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
Pfizer
INDUSTRY
Novartis
INDUSTRY
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Peter Friend
Role: STUDY_DIRECTOR
University of Oxford
Colin Baigent
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Martin J Landray
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Paul Harden
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Richard Haynes
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Oxford Radcliffe Hospitals NHS Trust
Oxford, Oxon, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Addenbrooke's Hospital NHS Trust
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
University Hospitals Coventry & Warwickshire
Coventry, , United Kingdom
Royal Infirmary
Edinburgh, , United Kingdom
Western Infirmary
Glasgow, , United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, , United Kingdom
Bart's and the London NHS Trust
London, , United Kingdom
Guy's and St Thomas's NHS Trust
London, , United Kingdom
Kings College Hospital NHS Trust
London, , United Kingdom
Royal Free Hampstead NHS Trust
London, , United Kingdom
Central Manchester NHS Trust
Manchester, , United Kingdom
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Plymouth Teaching Hospitals NHS Trust
Plymouth, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
Sheffield Teaching Hospitals NHS Trust
Sheffield, , United Kingdom
Countries
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References
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3C Study Collaborative Group; Haynes R, Harden P, Judge P, Blackwell L, Emberson J, Landray MJ, Baigent C, Friend PJ. Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial. Lancet. 2014 Nov 8;384(9955):1684-90. doi: 10.1016/S0140-6736(14)61095-3. Epub 2014 Jul 28.
3C Study Collaborative Group. Campath, calcineurin inhibitor reduction, and chronic allograft nephropathy (the 3C Study) - results of a randomized controlled clinical trial. Am J Transplant. 2018 Jun;18(6):1424-1434. doi: 10.1111/ajt.14619. Epub 2018 Jan 9.
Haynes R, Baigent C, Harden P, Landray M, Akyol M, Asderakis A, Baxter A, Bhandari S, Chowdhury P, Clancy M, Emberson J, Gibbs P, Hammad A, Herrington W, Jayne K, Jones G, Krishnan N, Lay M, Lewis D, Macdougall I, Nathan C, Neuberger J, Newstead C, Pararajasingam R, Puliatti C, Rigg K, Rowe P, Sharif A, Sheerin N, Sinha S, Watson C, Friend P; 3C Study Collaborative Group. Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol. Transplant Res. 2013 May 6;2(1):7. doi: 10.1186/2047-1440-2-7.
Provided Documents
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Document Type: Statistical Analysis Plan: Induction Therapy Data Analysis Plan
Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Maintenance Therapy Data Analysis Plan
Related Links
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3C study website
Other Identifiers
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2008-008553-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISRCTN88894088
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTSU3C1
Identifier Type: -
Identifier Source: org_study_id
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