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Thymoglobulin Induction in Kidney Transplant Recipients (TIKT)

Primary Purpose

Kidney Transplantation, Ischemia-Reperfusion Injury

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
antithymocyte globulin
Basiliximab
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring kidney transplantation, donation after cardiac death, ischemia-reperfusion injury, thymoglobulin, steroid avoidance, lymphocyte

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oxford Transplant Centre, Churchill Hospital
  • University of Oxford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thymoglobulin

Basiliximab

Arm Description

Thymoglobulin induction group

Basiliximab induction - 20 mg, day 0 and day 4

Outcomes

Primary Outcome Measures

delayed graft function

Secondary Outcome Measures

steroid avoidance
lymphocyte repopulation

Full Information

First Posted
November 10, 2010
Last Updated
November 10, 2010
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01239563
Brief Title
Thymoglobulin Induction in Kidney Transplant Recipients
Acronym
TIKT
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Ischemia-Reperfusion Injury
Keywords
kidney transplantation, donation after cardiac death, ischemia-reperfusion injury, thymoglobulin, steroid avoidance, lymphocyte

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thymoglobulin
Arm Type
Experimental
Arm Description
Thymoglobulin induction group
Arm Title
Basiliximab
Arm Type
Active Comparator
Arm Description
Basiliximab induction - 20 mg, day 0 and day 4
Intervention Type
Drug
Intervention Name(s)
antithymocyte globulin
Other Intervention Name(s)
Thymoglobulin, L04AA04
Intervention Description
Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose
Intervention Type
Drug
Intervention Name(s)
Basiliximab
Other Intervention Name(s)
Simulect
Intervention Description
Intravenous 20mg, day 0&4
Primary Outcome Measure Information:
Title
delayed graft function
Time Frame
7 days
Secondary Outcome Measure Information:
Title
steroid avoidance
Time Frame
1 year
Title
lymphocyte repopulation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS
Phone
44 1865 741841
Email
anand.muthusamy@orh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Brockmann, MD
Phone
44 1865 741841
Email
jens.brockmann@nds.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Friend, MD FRCS
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan V Fuggle, DPhil MRCPath
Organizational Affiliation
Oxford Radclifffe Hospitals NHS Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kathryn Wood, DPhil BSc
Organizational Affiliation
University of Oxford
Official's Role
Study Director
Facility Information:
Facility Name
Oxford Transplant Centre, Churchill Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan V Fuggle, DPhil MRCPath
Phone
44 1864 226162
Email
susan.fuggle@nds.ox.ac.uk
Facility Name
University of Oxford
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Wood, DPhil BSc
First Name & Middle Initial & Last Name & Degree
Peter J Friend, MD FRCS
First Name & Middle Initial & Last Name & Degree
Kathryn Wood, DPhil BSc

12. IPD Sharing Statement

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Thymoglobulin Induction in Kidney Transplant Recipients

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