Status:
UNKNOWN
Thymoglobulin Induction in Kidney Transplant Recipients
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Oxford University Hospitals NHS Trust
Genzyme, a Sanofi Company
Conditions:
Kidney Transplantation
Ischemia-Reperfusion Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01239563
Start Date
January 1 2011
End Date
May 1 2016
Last Update
November 11 2010
Active Locations (2)
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1
Oxford Transplant Centre, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
2
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU