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Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy
ISRCTN ISRCTN88894088
DOI 10.1186/ISRCTN88894088
ClinicalTrials.gov identifier NCT01120028
EudraCT number 2008-008553-27
Public title Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy
Scientific title Open-label, randomised multicentre study of CAMPATH-1H versus basiliximab induction treatment and sirolimus versus tacrolimus maintenance treatment for the preservation of renal function in patients receiving kidney transplants
Acronym The 3C Study
Serial number at source CTSU3C1
Study hypothesis Reducing exposure to calcineurin inhibitors either by using more potent antibody induction (Campath) and/or an elective switch to sirolimus-based immunosuppression may improve function and survival of kidney transplants.
Lay summary Lay summary under review 3
Ethics approval Nottingham Research Ethics Committee (REC) 2 approved on the 2nd of December 2009 (ref: 09/H0408/101)
Study design Open label multicentre randomised controlled 2x2 factorial trial
Countries of recruitment United Kingdom
Disease/condition/study domain Kidney transplantation
Participants - inclusion criteria 1. Men or women aged over 18 years
2. Recipient of kidney transplant from live or deceased donor
Participants - exclusion criteria 1. Recipients of multi-organ transplants
2. Previous treatment with Campath-1H
3. Active infection
4. Past history of anaphylaxis to humanized monoclonal antibodies
5. History of malignancy (except for adequately treated non-melanoma skin cancer)
6. Loss of previous transplant within 6 months not due to technical reasons
7. Medical history that might limit the participant's ability to take trial treatments for the duration of the study
Anticipated start date 01/09/2010
Anticipated end date 31/08/2017
Status of trial Ongoing
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 800
Interventions 1. Campath-1H: 30 mg on days 0 and 1 (intravenously or subcutaneously)
2. Basiliximab 20mg on days 0 and 4 (intravenously)
3. Tacrolimus: oral tablets
3.1. target trough level 8-12 ng/mL following basiliximab induction for first six months
3.2. target trough level 5-7 ng/mL following Campath-1H induction and in all patients after 6 months. For duration of study.
4. Sirolimus: oral tablets; target trough level 5-10 ng/mL for first 6 months then 5-8 ng/mL. For duration of study.
The total duration of follow up is at least 5 years for all treatment arms.
Primary outcome measure(s) 1. Induction therapy comparison: biopsy-proven acute rejection at 6 months
2. Maintenance therapy comparison: graft function at 2 years
Secondary outcome measure(s) 1. Graft function and survival
2. Patient survival
3. Incidence of serious infections
4. Incidence of malignancy
5. Major vascular events
All secondary outcomes will be assessed at 1, 2 and 5 years
Sources of funding 1. NHS Blood and Transplant Research and Development (UK) (ref 09-15-01-03)
2. Pfizer (UK)
3. Novartis (UK)
4. (Pending application with Health Technology Assessment Clinical Trials program)
Trial website
Publications 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25078310
Contact name Prof  Peter  Friend
  Address Oxford Transplant Centre
Churchill Hospital
Headington
  City/town Oxford
  Zip/Postcode OX3 7LJ
  Country United Kingdom
  Email ccc@ctsu.ox.ac.uk
Sponsor University of Oxford (UK)
  Address Research Services
Clinical Trials and Research Governance
Manor House
John Radcliffe Site
Headington
  City/town Oxford
  Zip/Postcode OX3 9DZ
  Country United Kingdom
  Tel +44 (0)1865 270000
  Fax +44 (0)1865 743002
  Email heather.house@admin.ox.ac.uk
  Sponsor website: http://www.admin.ox.ac.uk/rso
Date applied 06/05/2010
Last edited 01/08/2014
Date ISRCTN assigned 07/06/2010
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