Thymoglobulin Induction in Kidney Transplant Recipients (TIKT)

November 10, 2010 updated by: University of Oxford

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Oxford Transplant Centre, Churchill Hospital
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
delayed graft function
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
steroid avoidance
Time Frame: 1 year
1 year
lymphocyte repopulation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Genzyme, a Sanofi Company
Oxford University Hospitals NHS Trust

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oxford/OTC/TIKT
  • 2009-016676-73 (Registry Identifier: EUDRACT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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