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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017066-23 | EudraCT Number | ||
| 95769119 | Registry Identifier | ISRCTN | |
| 9154 | Registry Identifier | UK Clinical Research Network (CRN) Portfolio |
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| Name | Class |
|---|---|
| Astellas Pharma Europe Ltd. | INDUSTRY |
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Hypothesis:
Aim:
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Rituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone |
|
| Control group | Active Comparator | Low dose tacrolimus with mycophenylate mofetil and continued prednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 375mg/m^2, single dose given 2-4 weeks prior to transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated GFR (calculated using the Cockcroft-Gault formula) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy proven acute rejection (based on Banff classification) | 1, 2, 3, 4, 5 years | |
| Allograft survival | 1, 2, 3, 4, 5 years | |
| Patient Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nizam Mamode, MD FRCS(Gen) | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South West Transplant Centre | Plymouth | Devon | PL6 8DH | United Kingdom | ||
| East Kent Hospitals NHS Foundation Trust |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D006854 | Hydrocortisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Tacrolimus | Drug | dose calculated to give levels of 3-7ng/ml |
|
|
| Mycophenylate mofetil | Drug | Mycophenylate mofetil 2g/day in divided doses |
|
|
| Hydrocortisone | Drug | 100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant. |
|
| Prednisolone | Drug | Prednisolone 0.3mg/kg on day 2, 0.25mg/kg on day 3, 0.2mg/kg on day 4 and 0.16mg/kg on day 5. On day 6 they will receive 5mg prednisolone, and on day 7 none. |
|
| Prednisolone | Drug | Reducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician. |
|
| 1, 2, 3, 4, 5 years |
| Infection rate | New episodes, including (but not restricted to) viral (e.g. CMV, EBV), bacterial (e.g. Urinary Tract Infections with details of causative organism) and fungal infections will be recorded at each assessment time-point. | 1 year |
| Changes in B and T cell repertoire | 1 year |
| Canterbury |
| Kent |
| CT1 3NG |
| United Kingdom |
| Glasgow Renal and Transplant Unit | Glasgow | G11 6NT | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| Central Manchester University Hospitals NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
| Sheffield Kidney Institute | Sheffield | S5 7AU | United Kingdom |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |