Mycophenolate Mofetil versus Cyclosporin A in Children with Frequently Relapsing Nephrotic Syndrome
Open Access
- 1 October 2013
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Journal of the American Society of Nephrology
- Vol. 24 (10), 1689-1697
- https://doi.org/10.1681/asn.2012121200
Abstract
The severe side effects of long-term corticosteroid or cyclosporin A (CsA) therapy complicate the treatment of children with frequently relapsing steroid-sensitive nephrotic syndrome (FR-SSNS). We conducted a randomized, multicenter, open-label, crossover study comparing the efficacy and safety of a 1-year treatment with mycophenolate mofetil (MMF; target plasma mycophenolic acid trough level of 1.5–2.5 µg/ml) or CsA (target trough level of 80–100 ng/ml) in 60 pediatric patients with FR-SSNS. We assessed the frequency of relapse as the primary endpoint and evaluated pharmacokinetic profiles (area under the curve [AUC]) after 3 and 6 months of treatment. More relapses per patient per year occurred with MMF than with CsA during the first year (P=0.03), but not during the second year (P=0.14). No relapses occurred in 85% of patients during CsA therapy and in 64% of patients during MMF therapy (P=0.06). However, the time without relapse was significantly longer with CsA than with MMF during the first year (PP=0.36). In post hoc analysis, patients with low mycophenolic acid exposure (AUC 50 µg⋅h/ml; P<0.05). There were no significant differences between groups with respect to BP, growth, lipid levels, or adverse events. However, cystatin clearance, estimated GFR, and hemoglobin levels increased significantly with MMF compared with CsA. These results indicate that MMF is inferior to CsA in preventing relapses in pediatric patients with FR-SSNS, but may be a less nephrotoxic treatment option.Keywords
This publication has 31 references indexed in Scilit:
- Mycophenolate mofetil for steroid-dependent nephrotic syndrome: a phase II Bayesian trialPediatric Nephrology, 2011
- Long-term effects of cyclophosphamide therapy in steroid-dependent or frequently relapsing idiopathic nephrotic syndromeNephrology Dialysis Transplantation, 2010
- Risk Factors for Cyclosporin A Nephrotoxicity in Children with Steroid-Dependant Nephrotic SyndromeClinical Journal of the American Society of Nephrology, 2009
- New Equations to Estimate GFR in Children with CKDJournal of the American Society of Nephrology, 2009
- Treatment with mycophenolate mofetil and prednisolone for steroid-dependent nephrotic syndromePediatric Nephrology, 2007
- A prospective study on the use of mycophenolate mofetil in children with cyclosporine-dependent nephrotic syndromePediatric Nephrology, 2006
- Mycophenolate mofetil therapy in frequently relapsing steroid-dependent and steroid-resistant nephrotic syndrome of childhood: current status and future directionsPediatric Nephrology, 2005
- Efficacy of mycophenolate mofetil in pediatric patients with steroid-dependent nephrotic syndromePediatric Nephrology, 2005
- Mycophenolate mofetil in steroid/cyclosporine-dependent/resistant nephrotic syndromePediatric Nephrology, 2005
- The primary nephrotic syndrome in children. Identification of patients with minimal change nephrotic syndrome from initial response to prednisone: A report of the international study of kidney disease in childrenThe Journal of Pediatrics, 1981