Clinical trial NCT01239563: Thymoglobulin Induction in Kidney Transplant Recipients
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Transplantation
Ischemia-Reperfusion Injury
Keywords: kidney transplantation
donation after cardiac death
ischemia-reperfusion injury
thymoglobulin
steroid avoidance
lymphocyte
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: Genzyme, a Sanofi Company
First posted: 2010-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: delayed graft function
timeFrame: 7 days
Secondary outcomes:
measure: steroid avoidance
timeFrame: 1 year
measure: lymphocyte repopulation
timeFrame: 1 year
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Transplant Centre, Churchill Hospital
state: Oxfordshire
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Peter J Friend, MD FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford Radclifffe Hospitals NHS Trust
name: Susan V Fuggle, DPhil MRCPath
role: STUDY_DIRECTOR
affiliation: University of Oxford
name: Kathryn Wood, DPhil BSc
role: STUDY_DIRECTOR
References: