Thymoglobulin Induction in Kidney Transplant Recipients
Information source: University of Oxford
ClinicalTrials.gov processed this data on August 23, 2015 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 avoidancelymphocyte 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
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
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
Additional Information
Starting date: January 2011
Last updated: November 10, 2010
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