Trial reportAmerican journal of kidney diseases : the official journal of the National Kidney Foundation2010
Phase 1 trial of adalimumab in Focal Segmental Glomerulosclerosis (FSGS): II. Report of the FONT (Novel Therapies for Resistant FSGS) study group.
Trial report in American journal of kidney diseases : the official journal of the National Kidney Foundation, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 4 of them syntheses that pooled it.
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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
54 citing papers in PubMed, 4 syntheses or guidelines pooled it, 88 citations in OpenAlex.
- Interventions for idiopathic steroid-resistant nephrotic syndrome in children.The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy and safety of nine immunosuppressive agents for primary focal segmental glomerulosclerosis in adults: a pairwise and network meta-analysis.Renal failure · 2024Pooled 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
- Intrinsic tumor necrosis factor-α pathway is activated in a subset of patients with focal segmental glomerulosclerosis.PloS one · 2019Trial
- A possible influence of age on absorption and elimination of adalimumab in focal segmental glomerulosclerosis (FSGS).European journal of clinical pharmacology · 2016Trial
- Efficacy of galactose and adalimumab in patients with resistant focal segmental glomerulosclerosis: report of the font clinical trial group.BMC nephrology · 2015Trial
- Clinical Features and Histology of Apolipoprotein L1-Associated Nephropathy in the FSGS Clinical Trial.Journal of the American Society of Nephrology : JASN · 2015Trial
- Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design.BMC nephrology · 2011Trial
- Review
- Proteinuria and influence on monoclonal antibody excretion: a pembrolizumab case report and literature review.CEN case reports · 2025Review
- A new era in the treatment of kidney diseases: NLRP3 inflammasome and cytokine-targeted therapies.Pediatric nephrology (Berlin, Germany) · 2025Review
- Population pharmacokinetic analysis of bevacizumab in Japanese cancer patients with proteinuria: a prospective cohort study.Cancer chemotherapy and pharmacology · 2025Article
- Precision Medicine Proof-of-Concept Study of a TNF Inhibitor in FSGS and Treatment-Resistant Minimal Change Disease.Kidney360 · 2025Article
- Advances in Focal Segmental Glomerulosclerosis Treatment From the Perspective of the Newest Mechanisms of Podocyte Injury.Drug design, development and therapy · 2025Review
- Article
- Podocyte-targeted therapies - progress and future directions.Nature reviews. Nephrology · 2024Review
- Low serum concentrations of bevacizumab and nivolumab owing to excessive urinary loss in patients with proteinuria: a case series.Cancer chemotherapy and pharmacology · 2024Article
- Ferroptosis-related genes, a novel therapeutic target for focal segmental glomerulosclerosis.BMC nephrology · 2024Article
- Rationale and design of the Nephrotic Syndrome Study Network (NEPTUNE) Match in glomerular diseases: designing the right trial for the right patient, today.Kidney international · 2024Article
Corrections and comments
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Authors and funding
13 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundPatients with primary focal segmental glomerulosclerosis (FSGS) resistant to current treatment regimens are at high risk of progression to end-stage kidney disease. Antifibrotic agents, such as tumor necrosis factor alpha antagonists, are a promising strategy to slow or halt the decline in renal function, based on preclinical and clinical data. STUDY
designPhase 1 clinical trial to assess the pharmacokinetics, tolerability, and safety of adalimumab, a human monoclonal antibody to tumor necrosis factor alpha. SETTING &
participants10 patients (4 male and 6 female) aged 16.8 +/- 9.0 years with an estimated glomerular filtration rate of 105 +/- 50 mL/min/1.73 m(2) were studied.
interventionAdalimumab, 24 mg/m(2), every 14 days for 16 weeks (total, 9 doses). OUTCOMES: Pharmacokinetic assessment, tolerability, and safety. MEASUREMENTS: Estimated glomerular filtration rate, proteinuria, and pharmacokinetic assessment after initial dosing and steady state.
resultsPharmacokinetic evaluation indicated that the area under the curve was decreased by 54% (P < 0.001) and clearance was increased by 160% (P < 0.01) in patients with resistant FSGS compared with healthy controls and patients with rheumatoid arthritis. Adalimumab was well tolerated with no serious adverse events or infectious complications attributable to the drug. Proteinuria decreased by > or = 50% in 4 of 10 treated patients. LIMITATIONS: Insufficient power to assess the safety or efficacy of adalimumab therapy for patients with resistant FSGS.
conclusionsPharmacokinetic assessment showed increased clearance of adalimumab in patients with resistant primary FSGS and validated the need to evaluate the disposition of novel therapies for this disease to define appropriate dosing regimens. The study provides a rationale to evaluate the efficacy of adalimumab as an antifibrotic agent for resistant FSGS in phase 2/3 clinical trials.
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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.