Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome.
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/m(2) 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 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.
Dorresteijn
Eiske M
EM
Department of Pediatric Nephrology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands. e.dorresteijn@erasmusmc.nl
Kist-van Holthe
Joana E
JE
Levtchenko
Elena N
EN
Nauta
Jeroen
J
Hop
Wim C J
WC
van der Heijden
Albert J
AJ
D000293:Adolescent; D001706:Biopsy; D001794:Blood Pressure; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D018572:Disease-Free Survival; D005260:Female; D005885:Gingival Hyperplasia / Q000139:chemically induced; D005919:Glomerular Filtration Rate; D006801:Humans; D006983:Hypertrichosis / Q000139:chemically induced; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D009402:Nephrosis, Lipoid / Q000188:drug therapy* / Q000473:pathology; D012074:Remission Induction; D055502:Secondary Prevention; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid