Trial reportPediatric nephrology (Berlin, Germany)2012
Mycophenolate mofetil for steroid-dependent nephrotic syndrome: a phase II Bayesian trial.
Trial report in Pediatric nephrology (Berlin, Germany), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- Clinical practice guideline for pediatric idiopathic nephrotic syndrome 2013: medical therapy.Clinical and experimental nephrology · 2015Guideline
- Randomized controlled trial on immunomodulatory effects of azithromycin in children with steroid-dependent nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2019Trial
- Mycophenolate mofetil versus cyclosporin A in children with frequently relapsing nephrotic syndrome.Journal of the American Society of Nephrology : JASN · 2013Trial
- Article
- Recent Advances in Therapeutic Drug Monitoring of Voriconazole, Mycophenolic Acid, and Vancomycin: A Literature Review of Pediatric Studies.Pharmaceutics · 2021Review
- The safety and efficacy of mycophenolate mofetil in children and adolescents with steroid-dependent nephrotic syndrome: a single-centre study.Clinical kidney journal · 2020Article
- Long-term outcome of Japanese children with complicated minimal change nephrotic syndrome treated with mycophenolate mofetil after cyclosporine.Pediatric nephrology (Berlin, Germany) · 2019Article
- Treating the idiopathic nephrotic syndrome: are steroids the answer?Pediatric nephrology (Berlin, Germany) · 2019Review
- Effect of different rituximab regimens on B cell depletion and time to relapse in children with steroid-dependent nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2019Article
- Mycophenolate mofetil for sustained remission in nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2018Article
- Initial treatment of steroid-sensitive idiopathic nephrotic syndrome in children with mycophenolate mofetilBMJ open · 2018Article
- Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.Journal of clinical pharmacology · 2018Review
- Mycophenolate mofetil following glucocorticoid treatment in Henoch-Schönlein purpura nephritis: the role of early initiation and therapeutic drug monitoring.Pediatric nephrology (Berlin, Germany) · 2018Article
- Efficacy of mycophenolate treatment in adults with steroid-dependent/frequently relapsing idiopathic nephrotic syndrome.Clinical kidney journal · 2017Article
- Evaluation of Mycophenolate Mofetil and Low-Dose Steroid Combined Therapy in Moderately Severe Henoch-Schönlein Purpura Nephritis.Medical science monitor : international medical journal of experimental and clinical research · 2017Article
- The Roche Total Mycophenolic Acid® assay: An application protocol for the ABX Pentra 400 analyzer and comparison with LC-MS in children with idiopathic nephrotic syndrome.Practical laboratory medicine · 2017Article
- Long-term efficacy and safety of common steroid-sparing agents in idiopathic nephrotic children.Clinical and experimental nephrology · 2017Article
- Pharmacokinetics of mycophenolic acid in children with clinically stable idiopathic nephrotic syndrome receiving cyclosporine.Clinical and experimental nephrology · 2017Article
- Mycophenolate mofetil in steroid-dependent idiopathic nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2016Observational
- A single-centre retrospective study of the safety and efficacy of mycophenolate mofetil in children and adolescents with nephrotic syndrome.Clinical kidney journal · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Mycophenolate mofetil (MMF) has emerged as a new therapeutic option in steroid-dependent nephrotic syndrome (SDNS). We conducted a phase II Bayesian trial of MMF in children with SDNS. Phase II trials, usually single-arm studies, investigate the effect of new treatments. Standard Fleming's procedure relies on observed results (relapse rate during the trial), whereas Bayesian approach combines observed results with prior information (expected relapse rate according to prior studies and clinical experience). All patients were required to have received prior alkylating-agent treatment. Sixty-seven percent of them had also received levamisole. Patients received MMF (1,200 mg/m(2)/day) and prednisone according to a defined schedule [reduction of alternate-day (e.o.d) dose to 50% of pre-MMF dose at 3 months, 25% at 6 months]. Twenty-four children (median age 6.0 years, 2.8-14.4) entered the study and 23 completed it. Bayesian analysis showed that adding four patients would not change significance of results, allowing stopping inclusions. Four patients relapsed during the first 6 months (estimated probability 17.6%, 95% credibility interval: 5.4-35.0%) and two at months 8 and 11.5. In the 19 patients free of relapse during the first 6 months, median (Q1-Q3) prednisone maintenance dose decreased from 25 (10-44) to 9 (7.5-11.2) mg/m(2) e.o.d (p < 0.001) and cumulative dose from 459 (382-689) to 264 (196-306) mg/m(2)/month (p < 0.001) before and on MMF respectively. Pre-MMF patient characteristics and MMF pharmacokinetics did not differ between patients with or without relapse. MMF reduces relapse rate and steroid dose in children with SDNS and should be proposed before cyclosporine and cyclophosphamide.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.