PMID: identifiant
de la référence Pubmed : |
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 (22257543) |
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| titre : |
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A multicenter, randomized trial of increased mycophenolic acid dose using enteric-coated mycophenolate sodium with reduced tacrolimus exposure in maintenance kidney transplant recipients. |
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| auteur(s) : |
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Nassim Kamar ( ) 1, Lionel Rostaing1, Elisabeth Cassuto2, Florence Villemain3, Marie-Christine Moal4, Marc Ladrière5, Benoît Barrou6, Didier Ducloux7, Kamel Chaouche8, Stephane Quéré8, Fabienne Di Giambattista8, François Be9 |
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| laboratoire : |
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| résumé : |
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Mycophenolic acid (MPA) dose is frequently reduced in tacrolimus-treated kidney transplant patients, but alternatively the recommended MPA dose can be maintained with reduced tacrolimus exposure. In a 6-month, multicenter, randomized, openlabel study, maintenance kidney transplant patients receiving MPA (mycophenolate mofetil 1g/d or enteric-coated mycophenolate sodium (EC-MPS) 720 mg/d) and tacrolimus were randomized to convert to EC-MPS 1,440 mg/d with reduced tacrolimus (n = 46), or receive EC-MPS 720 mg/d with unchanged tacrolimus (n = 48). Mean estimated GFR (eGFR, aMDRD) at Month 6 was 49.1 ± 11.1 and 44.7 ± 11.5 ml/min/1.73 m2 in the EC-MPS 1,440 mg and 720 mg groups, respectively (p = 0.07). The primary endpoint, change in eGFR from Day 0 to Month 6, was 2.48 ± 0.95 ml/min/1.73 m2 with EC-MPS 1,440 mg and -0.48 ± 0.93 ml/min/1.73 m2 with EC-MPS 720 mg (difference 2.96 ml/min/1.73 m2; 95% CI 0.32 - 5.60; p = 0.028). There were no deaths, graft losses or acute rejections. Adverse events were more frequent with EC-MPS 1,440 mg than 720 mg (66.7% vs. 44.7%, p = 0.034). Adverse events with suspected relation to EC-MPS occurred in 26.7% and 21.3% of patients, respectively (p = 0.59). Conversion of kidney transplant patients to increased MPA dosing using EC-MPS 1,440 mg/d, with reduced tacrolimus exposure, appears an effective immunosuppression strategy and may improve renal function. Adverse events overall, but not those with a suspected relation to EC-MPS, were higher with ECMPS 1,440 mg/d. |
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| domaine : |
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Sciences du Vivant/Immunologie
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langue du texte
intégral : |
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Anglais |
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| ISSN : |
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0301-0430 |
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| type de publication : |
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Articles dans des revues avec comité de lecture |
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| journal : |
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| Clinical Nephrology (Clin Nephrol) |
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Dustri-Verlag |
| ISSN |
0301-0430 |
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| Audience : |
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internationale |
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| date de publication : |
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02/2012 |
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| volume : |
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77 |
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| numéro : |
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2 |
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| page, identifiant, ... : |
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126-36 |
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| Descripteur(s) MeSH : |
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Adolescent – Adult – Aged – Creatinine – Female – Glomerular Filtration Rate – Humans – Immunosuppressive Agents – Kidney Transplantation – Male – Middle Aged – Mycophenolic Acid – Prospective Studies – Tablets – Enteric-Coated – Tacrolimus |
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