Thymoglobulin Induction in Kidney Transplant Recipients

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Genzyme, a Sanofi Company; Oxford University Hospitals NHS Trust
• Treatments: Antibodies, Monoclonal; Antilymphocyte Serum; Basiliximab; Thymoglobulin

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