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Thymoglobulin Induction in Kidney Transplant Recipients (TIKT)

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ClinicalTrials.gov Identifier: NCT01239563
Recruitment Status : Unknown
Verified November 2010 by University of Oxford.
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2010
Last Update Posted : November 11, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline) administration in the kidney transplant recipient is able to reduce the amount of damage that kidneys transplanted from deceased donors sustains on reperfusion.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Ischemia-Reperfusion Injury Drug: antithymocyte globulin Drug: Basiliximab Phase 3

Detailed Description:
The increasing disparity between organ availability and the number of patients on waiting list for a transplant has led to different strategies to improve half life of all transplants. One such method is to reduce the amount of damage the organ sustains during the period of preservation and reperfusion in the recipient. Thymoglobulin, an anti-lymphocyte antibody has been shown to have the ability to reduce this damage in experimental studies. This study aims to ascertain the role of Thymoglobulin in kidney transplants from donors after cardiac death, the type of kidney transplants at highest risk of sustaining injury during preservation. The study will involve comparison with conventional immunosuppressant therapy, comparison between Thymoglobulin administered in different doses, and observation of the patterns of blood cell repopulation (lymphocytes mainly) in the first year following kidney transplantation.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THYMOGLOBULIN INDUCTION AND STEROID-FREE IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTATION FROM DECEASED DONORS AFTER CARDIAC DEATH-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL TO EVALUATE THE ROLE OF THYMOGLOBULIN AS INDUCTION IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTS FROM DECEASED DONORS AFTER CARDIAC DEATH
Study Start Date : January 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Thymoglobulin
Thymoglobulin induction group
Drug: antithymocyte globulin
Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose
Other Name: Thymoglobulin, L04AA04
Active Comparator: Basiliximab
Basiliximab induction - 20 mg, day 0 and day 4
Drug: Basiliximab
Intravenous 20mg, day 0&4
Other Name: Simulect


Outcome Measures

Primary Outcome Measures :
  1. delayed graft function [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. steroid avoidance [ Time Frame: 1 year ]
  2. lymphocyte repopulation [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Male or Female, aged 18 years or above
  • Recipient of DCD kidney transplant
  • Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the first 12 months of the study
  • Able (in the Investigators opinion) and willing to comply with all study requirements
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria:

  • The participant may not enter the study if ANY of the following apply:
  • Failure of either recipient of a pair of kidneys to give consent
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
  • History of specific viral infection that would contraindicate depleting antibody therapy e.g. hepatitis B&C, HIV
  • Significant hepatic impairment-.i.e. Values 3 times upper limit of normal (unless this is usual for the subject)
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
  • Participants who have participated in another research study involving an investigational product in the previous 12 weeks
  • Previous administration of Thymoglobuline
  • Patients with functioning non-renal transplants and on immunosuppression
  • The patient is not suitable, in the opinion of the Investigator, to take part in the trial
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): NCT01239563


Contacts
Contact: Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS 44 1865 741841 anand.muthusamy@orh.nhs.uk
Contact: Jens Brockmann, MD 44 1865 741841 jens.brockmann@nds.ox.ac.uk

Locations
United Kingdom
Oxford Transplant Centre, Churchill Hospital Not yet recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Contact: Susan V Fuggle, DPhil MRCPath    44 1864 226162    susan.fuggle@nds.ox.ac.uk   
University of Oxford Not yet recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Kathryn Wood, DPhil BSc         
Principal Investigator: Peter J Friend, MD FRCS         
Principal Investigator: Kathryn Wood, DPhil BSc         
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Peter J Friend, MD FRCS University of Oxford
Study Director: Susan V Fuggle, DPhil MRCPath Oxford Radclifffe Hospitals NHS Trust
Study Director: Kathryn Wood, DPhil BSc University of Oxford
More Information

Responsible Party: Peter Friend / Professor of Transplantation, University of Oxford
ClinicalTrials.gov Identifier: NCT01239563     History of Changes
Other Study ID Numbers: Oxford/OTC/TIKT
2009-016676-73 ( Registry Identifier: EUDRACT )
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by University of Oxford:
kidney transplantation
donation after cardiac death
ischemia-reperfusion injury
thymoglobulin
steroid avoidance
lymphocyte

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Death
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Thymoglobulin
Antilymphocyte Serum
Basiliximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents