Trial reportBMC nephrology2011
Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design.
Trial report in BMC nephrology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02235857 (Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System
Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Interventions for idiopathic steroid-resistant nephrotic syndrome in children.The Cochrane database of systematic reviews · 2025Pooled it
- Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022Pooled it
- Interventions for idiopathic steroid-resistant nephrotic syndrome in children.The Cochrane database of systematic reviews · 2019Pooled it
- Efficacy of galactose and adalimumab in patients with resistant focal segmental glomerulosclerosis: report of the font clinical trial group.BMC nephrology · 2015Trial
- Kidney allograft fibrosis: what we learned from latest translational research studies.Journal of nephrology · 2020Review
- Assessing the Impact of Losmapimod on Proteinuria in Idiopathic Focal Segmental Glomerulosclerosis.Kidney international reports · 2020Article
- Epigenetic Modification Mechanisms Involved in Inflammation and Fibrosis in Renal Pathology.Mediators of inflammation · 2018Review
- Steroid-resistant nephrotic syndrome: a persistent challenge for pediatric nephrology.Pediatric nephrology (Berlin, Germany) · 2017Review
- Moxibustion Alleviates Injury in a Rat Focal Segmental Glomerulosclerosis Model.Evidence-based complementary and alternative medicine : eCAM · 2017Article
- Pathogenesis of Focal Segmental Glomerulosclerosis.Journal of pathology and translational medicine · 2016Review
- The glomerular permeability factors in idiopathic nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2016Review
- Serum glomerular albumin permeability activity: association with rapid progression to end-stage renal disease in focal segmental glomerulosclerosis.SpringerPlus · 2016Article
- A circulating permeability factor in focal segmental glomerulosclerosis: the hunt continues.Clinical kidney journal · 2015Review
- Macrophage-derived tumor necrosis factor-α mediates diabetic renal injury.Kidney international · 2015Article
- Therapeutic targets for treating fibrotic kidney diseases.Translational research : the journal of laboratory and clinical medicine · 2015Review
- Effect of immunosuppression on the human mesangial cell cycle.Molecular medicine reports · 2015Article
- Focal and segmental glomerulosclerosis: clinical and kidney biopsy correlations.Clinical kidney journal · 2014Article
- Drugs and trials: lessons from Plato.Clinical therapeutics · 2013Article
- Circulating suPAR in two cohorts of primary FSGS.Journal of the American Society of Nephrology : JASN · 2012Article
- Focal segmental glomerulosclerosis and chronic kidney disease in pediatric patients.Advances in chronic kidney disease · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 9 institutions in 2 countries.
Funding
Abstract
backgroundThe lack of adequate randomized clinical trials (RCT) has hindered identification of new therapies that are safe and effective for patients with primary focal segmental glomerulosclerosis (FSGS), especially in patients who fail to respond to corticosteroids and immunosuppressive therapies. Recent basic science advances have led to development of alternative treatments that specifically target aberrant pathways of fibrosis which are relevant to disease progression in FSGS. There is a need for a flexible Phase II study design which will test such novel antifibrotic strategies in order to identify agents suitable for phase III testing. METHODS/
designThe Novel Therapies for Resistant Focal Segmental Glomerulosclerosis (FONT) project is a multicenter Phase I/II RCT designed to investigate the potential efficacy of novel therapies for resistant FSGS. Adalimumab and galactose will be evaluated against conservative therapy consisting of the combination of lisinopril, losartan and atorvastatin. The sample size is defined to assure that if one of the treatments has a superior response rate compared to that of the other treatments, it will be selected with high probability for further evaluation. Comparison of primary and secondary endpoints in each study arm will enable a choice to be made of which treatments are worthy of further study in future Phase III RCT. DISCUSSION: This report highlights the key features of the FONT II RCT including the two-step outcome analysis that will expedite achievement of the study objectives. The proposed phase II study design will help to identify promising agents for further testing while excluding ineffective agents. This staged approach can help to prevent large expenditures on unworthy therapeutic agents in the management of serious but rare kidney diseases.
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What OpenQuestion holds
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.