Effective and safe treatment with cyclosporine in nephrotic children: A prospective, randomized multicenter trial

Ishikura, Kenji; Ikeda, Masato; Hattori, Shinzaburo; Yoshikawa, Norishige; Sasaki, Satoshi; Iijima, Kazumoto; Nakanishi, Koichi; Yata, Nahoko; Honda, Masashi

doi:10.1038/ki.2008.24

Cited by 85 publications

(52 citation statements)

References 31 publications

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“…Numerous studies have documented the prevalence of CsAN in patients who were treated for idiopathic nephrotic syndrome. Since 1986, Ͼ200 follow-up biopsies in patients who were treated with CsA for SDNS have been reported in the literature (1,(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27). These studies are difficult to compare because they vary in the number of biopsies, underlying renal pathology, duration of follow-up, dosages of CsA, and criteria to define CsAN.…”

Section: Discussionmentioning

confidence: 99%

Risk Factors for Cyclosporin A Nephrotoxicity in Children with Steroid-Dependant Nephrotic Syndrome

Kengne-Wafo¹,

Massella²,

Diomedi-Camassei

et al. 2009

Clinical Journal of the American Society of Nephrology

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Section: Discussionmentioning

confidence: 99%

Risk Factors for Cyclosporin A Nephrotoxicity in Children with Steroid-Dependant Nephrotic Syndrome

Kengne-Wafo¹,

Massella²,

Diomedi-Camassei

et al. 2009

Clinical Journal of the American Society of Nephrology

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“…The safety and efficacy of cyclosporine in children with frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS) have been demonstrated in a number of studies, including a randomized controlled trial (1)(2)(3)(4)(5)(6)(7)(8). We previously showed that microemulsified cyclosporine administered according to our treatment protocol is safe and effective in children with FRNS (2).…”

Section: Introductionmentioning

confidence: 93%

Two-Year Follow-Up of a Prospective Clinical Trial of Cyclosporine for Frequently Relapsing Nephrotic Syndrome in Children

Ishikura¹,

Yoshikawa

Nakazato

et al. 2012

Clinical Journal of the American Society of Nephrology

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SummaryBackground and objectives Although the safety and efficacy of cyclosporine in children with frequently relapsing nephrotic syndrome (FRNS) have been confirmed, no prospective follow-up data on relapse after cyclosporine have appeared. This study is a prospective follow-up trial after 2-year treatment with cyclosporine to investigate cyclosporine dependency after its discontinuation.Design, setting, participants, & measurements Participants who had undergone 2-year protocol treatment with microemulsified cyclosporine for FRNS between January 2000 and December 2005 were followed for an additional 2 years. The primary end point was relapse-free survival after the complete discontinuation of cyclosporine, and the secondary end point was regression-free survival (time to regression to FRNS).Results After exclusion of 7 patients who showed regression to FRNS during the 2-year treatment period, 49 children (median age, 6.5 years) were followed, and classified as children without (n=32; group A) and with (n=17; group B) relapse during the initial cyclosporine treatment. Overall, relapse-free survival probability at 24 months after cyclosporine discontinuation was 15.3% and regression to FRNS-free survival probability was 40.8%. By group, the probability of relapse-free survival was significantly higher in group A (17.9%) than in group B (8.3%) (P,0.001).Conclusions Children with FRNS who receive cyclosporine are at high risk of relapse after discontinuation, particularly those who experience relapse during cyclosporine treatment.

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“…Treatment with cyclosporin A (CsA) is highly effective in maintaining remission in patients with FR-SSNS allowing withdrawal of corticosteroids, but most patients relapse after withdrawal of CsA. 8 Importantly, prolonged CsA therapy is accompanied by time-and dose-dependent nephrotoxicity. 9 Mycophenolate mofetil (MMF), the prodrug of mycophenolic acid (MPA), is a non-nephrotoxic immunosuppressive drug with inhibitory effects on T and B lymphocytes, cellsurface markers, and cytokine gene expression 10 and has proven efficacy and tolerability in renal allograft recipients.…”

mentioning

confidence: 99%

Mycophenolate Mofetil versus Cyclosporin A in Children with Frequently Relapsing Nephrotic Syndrome

Gellermann

Weber

Pape

et al. 2013

Journal of the American Society of Nephrology

141

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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 mg/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 (P,0.05), but not during the second year (P=0.36). In post hoc analysis, patients with low mycophenolic acid exposure (AUC ,50 mgzh/ml) experienced 1.4 relapses per year compared with 0.27 relapses per year in those with high exposure (AUC.50 mgzh/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.

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Effective and safe treatment with cyclosporine in nephrotic children: A prospective, randomized multicenter trial

Cited by 85 publications

References 31 publications

Risk Factors for Cyclosporin A Nephrotoxicity in Children with Steroid-Dependant Nephrotic Syndrome

Risk Factors for Cyclosporin A Nephrotoxicity in Children with Steroid-Dependant Nephrotic Syndrome

Two-Year Follow-Up of a Prospective Clinical Trial of Cyclosporine for Frequently Relapsing Nephrotic Syndrome in Children

Mycophenolate Mofetil versus Cyclosporin A in Children with Frequently Relapsing Nephrotic Syndrome

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