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Thymoglobulin Induction in Kidney Transplant Recipients

Information source: University of Oxford
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation; Ischemia-Reperfusion Injury

Intervention: antithymocyte globulin (Drug); Basiliximab (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: University of Oxford

Official(s) and/or principal investigator(s):
Peter J Friend, MD FRCS, Principal Investigator, Affiliation: University of Oxford
Susan V Fuggle, DPhil MRCPath, Study Director, Affiliation: Oxford Radclifffe Hospitals NHS Trust
Kathryn Wood, DPhil BSc, Study Director, Affiliation: University of Oxford

Overall contact:
Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS, Phone: 44 1865 741841, Email: anand.muthusamy@orh.nhs.uk

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: delayed graft function

Secondary outcome:

steroid avoidance

lymphocyte repopulation

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS, Phone: 44 1865 741841, Email: anand.muthusamy@orh.nhs.uk

University of Oxford, Oxford, Oxfordshire OX3 9DU, United Kingdom; Not yet recruiting
Kathryn Wood, DPhil BSc
Peter J Friend, MD FRCS, Principal Investigator
Kathryn Wood, DPhil BSc, Principal Investigator

Oxford Transplant Centre, Churchill Hospital, Oxford, Oxfordshire OX3 7LJ, United Kingdom; Not yet recruiting
Susan V Fuggle, DPhil MRCPath, Phone: 44 1864 226162, Email: susan.fuggle@nds.ox.ac.uk

Additional Information

Starting date: January 2011
Last updated: November 10, 2010

Page last updated: February 07, 2013

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