Thymoglobulin Induction in Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

— TIKT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01239563
• Other study ID #: Oxford/OTC/TIKT
• Secondary ID: 2009-016676-73
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 10, 2010
• Last updated: November 10, 2010
• Start date: January 2011
• Est. completion date: May 2016

Study information

• Verified date: November 2010
• Source: University of Oxford
• Contact: Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS
• Phone: 44 1865 741841
• Email: anand.muthusamy[@]orh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia-Reperfusion Injury
• Kidney Transplantation
• Reperfusion Injury

Intervention

Drug:
• antithymocyte globulin
Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose
• Basiliximab
Intravenous 20mg, day 0&4

Locations

Country	Name	City	State
United Kingdom	Oxford Transplant Centre, Churchill Hospital	Oxford	Oxfordshire
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Genzyme, a Sanofi Company, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delayed graft function		7 days	No
Secondary	steroid avoidance		1 year	No
Secondary	lymphocyte repopulation		1 year	No