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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005572-28 | EudraCT Number |
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Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENVARSUS tablets | Experimental | Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths. Envarsus® tablets will be administered orally once daily in the morning |
|
| ADVAGRAF capsules | Active Comparator | Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths. Advagraf® capsules will be administered orally once daily in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENVARSUS® | Drug |
| ||
| ADVAGRAF® |
| Measure | Description | Time Frame |
|---|---|---|
| Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL | pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL | Whole blood trough drug concentration 24hour post dose | 24.0 hr post-dose |
| Serum creatinine (mg/dL) | before dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Department Hopital La Cavale Blanche | Brest | 296009 | France | |||
| Clinique de Nephrologie CHU Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30552587 | Result | Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14. |
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| estimated glomerular filtration rate (eGFR) mL/min; | before dosing |
| Heart Rate, (beats per minute) | before dosing |
| Qt (milliseconds) | before dosing |
| Grenoble |
| 38043 |
| France |
| CHU Limoges | Limoges | 87042 | France |
| Service de Nephrologie | Montpellier | 34295 | France |
| Unité de transplantation rénale -Hopital Pasteur | Nice | France |
| Nephrology department CHU de Saint-Etienne Hospital Nord | Saint-Etienne | 42055 | France |
| CHU Rangueil, 1 avenue J Poulhes TSA 50032. | Toulouse | 31400 | France |