Thymoglobulin Induction in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Transplantation, Ischemia-Reperfusion Injury

Intervention / Treatment
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* Drug: antithymocyte globulin
* Drug: Basiliximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymoglobulin<br>Thymoglobulin induction group | Drug: antithymocyte globulin<br>* Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose<br>* Other names: Thymoglobulin, L04AA04;|
| Active Comparator: Basiliximab<br>Basiliximab induction - 20 mg, day 0 and day 4 | Drug: Basiliximab<br>* Intravenous 20mg, day 0&4<br>* Other names: Simulect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delayed graft function |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| steroid avoidance |  | 1 year | 
| lymphocyte repopulation |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, donation after cardiac death, ischemia-reperfusion injury, thymoglobulin, steroid avoidance, lymphocyte