Thymoglobulin Induction in Kidney Transplant Recipients (TIKT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation Ischemia-Reperfusion Injury |
Drug: antithymocyte globulin Drug: Basiliximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- delayed graft function [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- steroid avoidance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- lymphocyte repopulation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Thymoglobulin
Thymoglobulin induction group
|
Drug: antithymocyte globulin
Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose
Other Name: Thymoglobulin, L04AA04
|
|
Active Comparator: Basiliximab
Basiliximab induction - 20 mg, day 0 and day 4
|
Drug: Basiliximab
Intravenous 20mg, day 0&4
Other Name: Simulect
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS | 44 1865 741841 | anand.muthusamy@orh.nhs.uk |
| Contact: Jens Brockmann, MD | 44 1865 741841 | jens.brockmann@nds.ox.ac.uk |
| United Kingdom | |
| University of Oxford | Not yet recruiting |
| Oxford, Oxfordshire, United Kingdom, OX3 9DU | |
| Contact: Kathryn Wood, DPhil BSc | |
| Principal Investigator: Peter J Friend, MD FRCS | |
| Principal Investigator: Kathryn Wood, DPhil BSc | |
| Oxford Transplant Centre, Churchill Hospital | Not yet recruiting |
| Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |
| Contact: Susan V Fuggle, DPhil MRCPath 44 1864 226162 susan.fuggle@nds.ox.ac.uk | |
| Principal Investigator: | Peter J Friend, MD FRCS | University of Oxford |
| Study Director: | Susan V Fuggle, DPhil MRCPath | Oxford Radclifffe Hospitals NHS Trust |
| Study Director: | Kathryn Wood, DPhil BSc | University of Oxford |
More Information
No publications provided
| Responsible Party: | Peter Friend / Professor of Transplantation, University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01239563 History of Changes |
| Other Study ID Numbers: | Oxford/OTC/TIKT, 2009-016676-73 |
| Study First Received: | November 10, 2010 |
| Last Updated: | November 10, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Oxford:
|
kidney transplantation donation after cardiac death ischemia-reperfusion injury |
thymoglobulin steroid avoidance lymphocyte |
Additional relevant MeSH terms:
|
Ischemia Reperfusion Injury Death Pathologic Processes Vascular Diseases Cardiovascular Diseases Postoperative Complications |
Antilymphocyte Serum Basiliximab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013