title: Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients.
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/m(2) per day during weeks 1-2, 810 +/- 193 mg/m(2) per day during months 3-6, and 827 +/- 153 mg/m(2) per day during months 6-12. The mean CsA C(2) 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 m(2) at month 6 and 100 +/- 16 mL/min per 1.73 m(2) at month 12. The majority of adverse events were mild or moderate (101/126, 80.2%). In this pilot study, EC-MPS 450 mg/m(2) 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.
authors.affiliation: Pediatric Nephrology, Necker Hospital, 161 rue de Sevres, 75743, Paris, Cedex, France. niaudet@necker.fr
authors.forename: Patrick
authors.initials: P
authors.lastname: Niaudet
authors.forename: Marina
authors.initials: M
authors.lastname: Charbit
authors.forename: Chantal
authors.initials: C
authors.lastname: Loirat
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Lapeyraque
authors.forename: Michel
authors.initials: M
authors.lastname: Tsimaratos
authors.forename: Mathilde
authors.initials: M
authors.lastname: Cailliez
authors.forename: Michel
authors.initials: M
authors.lastname: Foulard
authors.forename: Maud
authors.initials: M
authors.lastname: Dehennault
authors.forename: Pierre
authors.initials: P
authors.lastname: Marquet
authors.forename: Kamel
authors.initials: K
authors.lastname: Chaouche-Teyara
authors.forename: Djamila
authors.initials: D
authors.lastname: Lemay
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003404:Creatinine / Q000378:metabolism; D016572:Cyclosporine / Q000008:administration & dosage / Q000493:pharmacokinetics; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D016030:Kidney Transplantation; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000493:pharmacokinetics; D010865:Pilot Projects; D015375:Receptors, Interleukin-2 / Q000276:immunology; D013256:Steroids / Q000008:administration & dosage; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D015375:Receptors, Interleukin-2; D013256:Steroids; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D003404:Creatinine; D009173:Mycophenolic Acid