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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003184-29 | EudraCT Number |
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - tacrolimus half-dose | Experimental | Immunosuppressive strategy with 50 % reduction of Advagraf® daily dose at M4 (randomization) and unchanged MMF dose. Targeted tacrolimus trough level are to be higher than 3 ng/mL . If the dose is not in adequation with the dispensable units, the prescribed dose will be the closest higher dose. Drug: Tacrolimus targeted half-dose |
|
| Group B - tacrolimus unchanged dose | Experimental | Immunosuppressive strategy will remain identical after randomization (M4): unchanged Advagraf® and MMF doses. Targeted tacrolimus trough level are to be between 7 and 12 ng/mL Drug: Tacrolimus targeted plain dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus targeted half-dose | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function at one year post transplantation | Renal function at one year post transplantation estimated by the glomerular filtration rate (GFR) using MDRD 4 (Modification Diet in Renal Disease). Crude difference in renal function at one year between groups and the change of renal function between 4 months and one year in each group will be analyzed and compared. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine and compare according to randomized group | Routine graft histology at M12 assessed using Banff 2009 classification, with specific analysis of interstitial fibrosis (IF) using numeric quantification | 12 months |
| To determine and compare according to randomized group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvon LEBRANCHU | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Sud | Amiens | France | ||||
| CHU de Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27862923 | Derived | Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3. |
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| Tacrolimus targeted plain dose |
| Drug |
|
|
Glucose metabolism at M4 and M12 |
| 12 months |
| To determine and compare according to randomized group | Infection rate including BKV and CMV at M4 and M12 | 12 months |
| To determine and compare according to randomized group | Presence and intensity of Donor Specific Antibody (DSA) at M3 and M12 | 12 months |
| To determine and compare according to randomized group | Incidence of biopsy proven acute rejection episode at M12 | 12 months |
| To determine and compare according to randomized group | Graft and patient survival at M12 | 12 months |
| To determine and compare according to randomized group | Overall safety assessment | 12 months |
| Angers |
| France |
| Hôpital Bois-Guillaume | Bois-Guillaume | 76130 | France |
| Hôpital Cavale Blanche | Brest | France |
| CHU de Caen | Caen | France |
| Hôpital Gabriel Montpied | Clermont-Ferrand | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France |
| Hôpital Dupuytren | Limoges | France |
| Hôpital Archet II | Nice | France |
| HEGP | Paris | 75015 | France |
| Hôpital Necker | Paris | France |
| Hôpital Maison Blanche | Reims | France |
| Hôpital Pontchaillou | Rennes | France |
| Hôpital Civil | Strasbourg | France |
| CHU de Toulouse | Toulouse | France |
| CHRU de Tours | Tours | France |