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Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy (3C)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120028
First Posted: May 10, 2010
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Health Service, United Kingdom
Pfizer
Novartis
Information provided by (Responsible Party):
University of Oxford
  Purpose
The 3C study will investigate whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.

Condition Intervention Phase
Kidney Transplantation Drug: Alemtuzumab Drug: Basiliximab Drug: Sirolimus Drug: Tacrolimus Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Biopsy-proven acute rejection [ Time Frame: 6 months ]
    Primary outcome for induction therapy comparison

  • Graft function [ Time Frame: 2 and 5 years post-transplantation ]
    Primary outcome for maintenance therapy comparison


Secondary Outcome Measures:
  • Graft survival [ Time Frame: 6 months, 2 and 5 years ]
  • Serious infection [ Time Frame: 2 and 5 years ]
  • Malignancy [ Time Frame: 2 and 5 years ]
  • Major vascular event [ Time Frame: 2 and 5 years ]
    Composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death or arterial revascularization


Estimated Enrollment: 800
Study Start Date: September 2010
Estimated Study Completion Date: February 2019
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Campath-1H/Sirolimus
Induction therapy allocation: Campath-1H Maintenance therapy allocation (at 6 months post-transplant): Sirolimus
Drug: Alemtuzumab
Alemtuzumab 30 mg intravenously or subcutaneously Two doses 24 hours apart
Other Name: Campath-1H
Drug: Sirolimus
Sirolimus: target trough levels 5-10 ng/mL for first 6 months, then 5-8 ng/mL
Other Name: Rapamune
Experimental: Campath-1H/Tacrolimus
Induction therapy allocation: Campath-1H Maintenance therapy allocation (at 6 months post-transplant): Tacrolimus
Drug: Alemtuzumab
Alemtuzumab 30 mg intravenously or subcutaneously Two doses 24 hours apart
Other Name: Campath-1H
Drug: Tacrolimus
Target trough level 5-12 ng/mL for first 6 months after basiliximab; 5-7 ng/mL for first six months after basiliximab. 5-7 ng/mL for all participants after 6 months.
Other Name: Prograf
Active Comparator: Basliximab/Tacrolimus
Induction therapy allocation: Basiliximab Maintenance therapy allocation (at 6 months post-transplant): Tacrolimus
Drug: Basiliximab
20 mg intravenously Two doses 96 hours apart
Other Name: Simulect
Drug: Tacrolimus
Target trough level 5-12 ng/mL for first 6 months after basiliximab; 5-7 ng/mL for first six months after basiliximab. 5-7 ng/mL for all participants after 6 months.
Other Name: Prograf
Active Comparator: Basliximab/Sirolimus
Induction therapy allocation: Basiliximab Maintenance therapy allocation (at 6 months post-transplant): Sirolimus
Drug: Basiliximab
20 mg intravenously Two doses 96 hours apart
Other Name: Simulect
Drug: Sirolimus
Sirolimus: target trough levels 5-10 ng/mL for first 6 months, then 5-8 ng/mL
Other Name: Rapamune

Detailed Description:

The long-term survival of kidney transplants has not improved over the past decade despite reductions in the rate of acute rejection. The commonest cause of late graft loss is chronic allograft nephropathy which is frequently caused by calcineurin inhibitor toxicity. Therefore, it may be possible to improve long-term graft outcomes by reducing the amount of calcineurin inhibitor exposure.

Two possible strategies to do this will be tested. Firstly, Campath-1H (a monoclonal lymphocyte-depleting antibody) will be compared to standard basiliximab-based induction. All patients will then receive tacrolimus-based maintenance therapy for 6 months (using lower doses in the Campath-1H arm).

At six months, patients will be re-randomised between remaining on tacrolimus and converting to sirolimus (and therefore no longer take calcineurin inhibitors). Patients will then be followed-up in clinic and through routine NHS registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men or women aged over 18 years
  • recipient of kidney transplant (planned in next 24 hours)

Exclusion Criteria:

  • recipients of multi-organ transplant
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120028


Locations
United Kingdom
Oxford Radcliffe Hospitals NHS Trust
Oxford, Oxon, United Kingdom, OX3 7LJ
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
Sponsors and Collaborators
University of Oxford
National Health Service, United Kingdom
Pfizer
Novartis
Investigators
Study Director: Peter Friend University of Oxford
Principal Investigator: Colin Baigent University of Oxford
Principal Investigator: Martin J Landray University of Oxford
Principal Investigator: Paul Harden University of Oxford
Principal Investigator: Richard Haynes University of Oxford
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01120028     History of Changes
Other Study ID Numbers: CTSU3C1
2008-008553-27 ( EudraCT Number )
ISRCTN88894088 ( Registry Identifier: ISRCTN )
First Submitted: May 6, 2010
First Posted: May 10, 2010
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Tacrolimus
Sirolimus
Everolimus
Basiliximab
Calcineurin Inhibitors
Antibodies, Monoclonal
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents