Trial reportClinical journal of the American Society of Nephrology : CJASN2014
Cyclosporine C2 monitoring for the treatment of frequently relapsing nephrotic syndrome in children: a multicenter randomized phase II trial.
Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children.The Cochrane database of systematic reviews · 2024Pooled it
- Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children.The Cochrane database of systematic reviews · 2020Pooled it
- Combination therapy with or without warfarin and dipyridamole for severe childhood IgA nephropathy: an RCT.Pediatric nephrology (Berlin, Germany) · 2018Trial
- Positive role of rituximab in switching from cyclosporine to mycophenolate mofetil for children with high-dose steroid-dependent nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2015Trial
- Morbidity in children with frequently relapsing nephrosis: 10-year follow-up of a randomized controlled trial.Pediatric nephrology (Berlin, Germany) · 2015Trial
- A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment.Kidney international · 2015Trial
- Factors Influencing Cyclosporine Trough and Two-Hour Post-dose Concentrations in Children with Idiopathic Nephrotic Syndrome.Indian pediatrics · 2026Article
- Response predictors and long-term outcomes of preprandial single-daily cyclosporine in children with steroid-dependent nephrotic syndrome.Journal of nephrology · 2025Article
- Effective combination of corticosteroid and cyclosporine A for immunoglobulin A nephropathy with membranoproliferative glomerulonephritis features: a case report.CEN case reports · 2025Article
- Therapeutic drug monitoring in childhood idiopathic nephrotic syndrome: a state of the art review.Pediatric nephrology (Berlin, Germany) · 2024Review
- Update on the treatment of steroid-sensitive nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2022Review
- Cyclosporine A CClinical and experimental nephrology · 2022Article
- Is medium dose of cyclosporine A effective in treatment of children with steroid-dependent nephrotic syndrome with reduction in corticosteroids dose consumption?Clinical and experimental nephrology · 2019Article
- Positive effects of single-daily high-dose mizoribine therapy after cyclophosphamide in young children with steroid-dependent nephrotic syndrome.Clinical and experimental nephrology · 2019Article
- Effectiveness and nephrotoxicity of a 2-year medium dose of cyclosporine in pediatric patients with steroid-dependent nephrotic syndrome: determination of the need for follow-up kidney biopsy.Clinical and experimental nephrology · 2018Article
- Nephrotoxicity in children with frequently relapsing nephrotic syndrome receiving long-term cyclosporine treatment.Pediatric nephrology (Berlin, Germany) · 2017Article
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesAn open-label, multicenter, randomized phase II trial was conducted from July 1, 2005 to March 29, 2011 to compare two protocols for treating children with frequently relapsing nephrotic syndrome using microemulsified cyclosporine. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Ninety-three children with frequently relapsing nephrotic syndrome were randomly assigned to group A (n=46) or group B (n=47). In both groups, the 2-hour postdose cyclosporine level was monitored. For group A, the cyclosporine target was set to 600-700 ng/ml for the first 6 months and 450-550 ng/ml for the next 18 months; for group B, it was set to 450-550 ng/ml for the first 6 months and 300-400 ng/ml for the next 18 months. The primary end point was the sustained remission rate. At the end of the study, if there was no difference in safety profile between the two groups and the sustained remission rate in group A was superior to group B with a decision threshold of 8%, then the regimen for group A would be determined the better treatment.
resultsEight children from an ineligible institution, where cyclosporine levels were not measured, were excluded from all analyses. At 24 months, the sustained remission rate was nonsignificantly higher in group A (n=43) than group B (n=42; 64.4% versus 50.0%; hazard ratio, 0.57; 95% confidence interval, 0.29 to 1.11; P=0.09), and the progression-free survival rate was significantly higher (88.1% versus 68.4%; hazard ratio, 0.33; 95% confidence interval, 0.12 to 0.94; P=0.03). The relapse rate was significantly lower in group A than group B (0.41 versus 0.95 times/person-year; hazard ratio, 0.43; 95% confidence interval, 0.19 to 0.84; P=0.02). The rate and severity of adverse events were similar in both treatment groups.
conclusionThe sustained remission rate was not significantly different between the two treatment groups, but the regimen with the higher 2-hour postdose cyclosporine level target improved progression-free survival and reduced the relapse rate.
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