Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome
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ORIGINAL ARTICLE
Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome Eiske M. Dorresteijn & Joana E. Kist-van Holthe & Elena N. Levtchenko & Jeroen Nauta & Wim C. J. Hop & Albert J. van der Heijden
Received: 19 December 2007 / Revised: 20 May 2008 / Accepted: 20 May 2008 / Published online: 12 July 2008 # The Author(s) 2008
Abstract We performed a multi-centre randomized controlled trial to compare the efficacy of mycophenolate mofetil (MMF) to that of cyclosporine A (CsA) in treating children with frequently relapsing nephrotic syndrome and biopsy-proven minimal change disease. Of the 31 randomized initially selected patients, seven were excluded. The remaining 24 children received either MMF 1200 mg/m2 per day (n=12) or CsA 4–5 mg/kg per day (n=12) during a 12-month period. Of the 12 patients in the MMF group, two discontinued the study medication. Evaluation of the changes from the baseline glomerular filtration rate showed an overall significant difference in favour of MMF over the treatment period (p=0.03). Seven of the 12 patients in the MMF group and 11 of the 12 patients in the CsA group remained in complete remission during the entire study period. Relapse rate in the MMF group was 0.83/year compared to 0.08/year in the CsA group (p=0.08). None of E. M. Dorresteijn (*) : J. Nauta : A. J. van der Heijden Department of Pediatric Nephrology, Erasmus Medical Center/Sophia Children’s Hospital, Dr Molewaterplein 60, 3015 GJ Rotterdam, the Netherlands e-mail: [email protected] J. E. Kist-van Holthe Department of Pediatric Nephrology, Leiden University Medical Center, Leiden, the Netherlands E. N. Levtchenko Department of Pediatric Nephrology, University Hospital Leuven, Leuven, Belgium W. C. J. Hop Department of Epidemiology and Biostatistics, Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands
the patients reported diarrhea. Pharmacokinetic profiles of mycophenolic acid were performed in seven patients. The patient with the lowest area under the curve had three relapses within 6 months. In children with frequently relapsing minimal change nephrotic syndrome, MMF has a favourable side effect profile compared to CsA; however, there is a tendency towards a higher relapse risk in patients treated with MMF. Keywords Child . Cyclosporine . Frequent relapsing . Mycophenolate mofetil . Nephrotic syndrome
Introduction Nephrotic syndrome in children is primarily (77%) caused by minimal change disease [1]. The vast majority (92%) of these patients will respond well to corticosteroids. However, as many as 70% of children with nephrotic syndrome experience at least one relapse, and 30% will develop a more complicated course with frequent relapses (≥2 relapses/ 6 months) with or without steroid dependency (relapse during tapering or within 2 weeks after discontinuation of corticosteroids) [2, 3]. A short course of cyclophosphamide (2–3 months 2–3 mg/kg per day) will lead to prolonged remission in 25–60% of children with frequently relapsing nephrotic syndrome [4, 5].
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