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| ID | Type | Description | Link |
|---|---|---|---|
| PRG-EC-0243 | Other Identifier | Astellas Pharma Europe Ltd. |
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The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.
Comparing efficacy & safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | immunosuppression |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection: Incidence of and time to first biopsy proven acute rejection; overall frequency of acute rejections episodes; incidence of and time to first corticosteroid-resistant rejection; severity of biopsy-proven acute rejections (Banff97 criteria | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Physician | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | 1020 | Belgium | ||||
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| Label | URL |
|---|---|
| Link to FDA website | View source |
| Link to Results on EudraCT | View source |
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| mycophenolate mofetil | Drug | oral |
|
|
| daclizumab | Drug | oral |
|
| steroids | Drug | oral |
|
| Leuven |
| 3000 |
| Belgium |
| Prague | 150 06 | Czechia |
| Lyon | 69437 | France |
| Nantes | 44093 | France |
| Paris | 75935 | France |
| Berlin | 13353 | Germany |
| Cologne | 50924 | Germany |
| Hanover | 30625 | Germany |
| Heidelberg | 69120 | Germany |
| Budapest | 1082 | Hungary |
| Petah Tikva | 49100 | Israel |
| Genova | 16132 | Italy |
| Genova | 16147 | Italy |
| Milan | 20122 | Italy |
| Padova | 35128 | Italy |
| Rome | 00165 | Italy |
| Torino | 10126 | Italy |
| Warsaw | 04-730 | Poland |
| Cluj-Napoca | 400006 | Romania |
| Cape Town | South Africa |
| Johannesburg | South Africa |
| Gothenburg | 413 45 | Sweden |
| Taipei | Taiwan |
| Ankara | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| Birmingham | B4 6NH | United Kingdom |
| Bristol | BS2 8BJ | United Kingdom |
| Glasgow | G3 8SJ | United Kingdom |
| Leeds | LS9 7TF | United Kingdom |
| Liverpool | L12 2AP | United Kingdom |
| London | WC1 3JH | United Kingdom |
| Manchester | M27 4HA | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D000077561 | Daclizumab |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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