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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016676-73 | Registry Identifier | EUDRACT |
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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
| Genzyme, a Sanofi Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymoglobulin | Experimental | Thymoglobulin induction group |
|
| Basiliximab | Active Comparator | Basiliximab induction - 20 mg, day 0 and day 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antithymocyte globulin | Drug | Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| delayed graft function | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| steroid avoidance | 1 year | |
| lymphocyte repopulation | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS | Contact | 44 1865 741841 | anand.muthusamy@orh.nhs.uk | |
| Jens Brockmann, MD | Contact | 44 1865 741841 | jens.brockmann@nds.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Peter J Friend, MD FRCS | University of Oxford | Principal Investigator |
| Susan V Fuggle, DPhil MRCPath | Oxford Radclifffe Hospitals NHS Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Transplant Centre, Churchill Hospital | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Basiliximab | Drug | Intravenous 20mg, day 0&4 |
|
|
| Kathryn Wood, DPhil BSc |
| University of Oxford |
| Study Director |
| University of Oxford | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |