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Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients

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Abstract

Data on the use of enteric-coated mycophenolic acid (EC-MPS) in pediatric transplantation cases are scarce. We undertook a 12-month, multicenter, open-label pilot study in which 16 de novo renal transplant patients aged 5–16 years received EC-MPS with cyclosporine A microemulsion (CsA-ME), steroids, and anti-interleukin-2 receptor antibody induction. The mean dose of EC-MPS was 916 ± 93 mg/m2 per day during weeks 1–2, 810 ± 193 mg/m2 per day during months 3–6, and 827 ± 153 mg/m2 per day during months 6–12. The mean CsA C2 level exceeded target range up to month 6 post-transplant. Efficacy failure (biopsy-proven acute rejection, graft loss, death or loss to follow-up) occurred in two patients: one patient with primary non-function underwent nephrectomy, and one patient experienced biopsy-proven acute rejection (Grade 1B, day 344) following EC-MPS dose reduction. There were no deaths. Creatinine clearance (Schwartz) was 103 ± 30 mL/min per 1.73 m2 at month 6 and 100 ± 16 mL/min per 1.73 m2 at month 12. The majority of adverse events were mild or moderate (101/126, 80.2%). In this pilot study, EC-MPS 450 mg/m2 administered twice daily with CsA, steroids, and interleukin-2 antibody induction resulted in a low rate of rejection with good renal function in a pediatric population. However, a larger, controlled trial is required to confirm these results.

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Authors and Affiliations

  1. Pediatric Nephrology, Necker Hospital, 161 rue de Sevres, 75743, Paris, Cedex, France

    Patrick Niaudet & Marina Charbit

  2. Pediatric Nephrology, Robert Debré Hospital, 75019, Paris, Cedex, France

    Chantal Loirat & Anne-Laure Lapeyraque

  3. Pediatric Nephrology, AP-HM Timone-Enfants Hospital, 13385, Marseille, Cedex, France

    Michel Tsimaratos & Mathilde Cailliez

  4. Pediatric Nephrology, Hôpital Jeanne de Flandre, 59037, Lille, France

    Michel Foulard & Maud Dehennault

  5. INSERM U850, CHU de Limoges, Université de Limoges, Limoges, France

    Pierre Marquet

  6. Novartis France SAS, 92506, Rueil-Malmaison, Cedex, France

    Kamel Chaouche-Teyara & Djamila Lemay

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  1. Patrick Niaudet
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  2. Marina Charbit
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  3. Chantal Loirat
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Correspondence to Patrick Niaudet.

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Niaudet, P., Charbit, M., Loirat, C. et al. Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol 24, 395–402 (2009). https://doi.org/10.1007/s00467-008-1031-7

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  • DOI: https://doi.org/10.1007/s00467-008-1031-7

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