Thymoglobulin Induction in Kidney Transplant Recipients (TIKT)

University of Oxford

Status and phase: Unknown; Phase 3

Conditions: Kidney Transplantation; Ischemia-Reperfusion Injury

Treatments: Drug: Basiliximab; Drug: antithymocyte globulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01239563

Oxford/OTC/TIKT

2009-016676-73 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Thymoglobulin

Experimental group

Description:

Thymoglobulin induction group

Treatment:

Drug: antithymocyte globulin

Basiliximab

Active Comparator group

Description:

Basiliximab induction - 20 mg, day 0 and day 4

Treatment:

Drug: Basiliximab