Thymoglobulin Induction in Kidney Transplant Recipients (TIKT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2010 by University of Oxford
Sponsor:
Collaborators:
Oxford University Hospitals NHS Trust
Genzyme, a Sanofi Company
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01239563
First received: November 10, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention Phase
Kidney Transplantation
Ischemia-Reperfusion Injury
Drug: antithymocyte globulin
Drug: Basiliximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • delayed graft function [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • steroid avoidance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • lymphocyte repopulation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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         
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   
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

No publications provided

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
Study First Received: November 10, 2010
Last Updated: November 10, 2010
Health Authority: United Kingdom: Research Ethics Committee

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
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Basiliximab
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014