drugset / Trial / NCT00814255
Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial
Phase 2
Completed
32 enrolled
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabThe Cleveland Clinic · collabUniversity of Michigan · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This project will test whether adalimumab,and/or galactose can safely reduce proteinuria (abnormal amounts of protein in the urine) and protect kidney function better than standard treatment for patients with focal segmental glomerulosclerosis (FSGS).
Timeline
- Start
- 2008-12
- Primary completion
- 2013-06
- Completion
- 2014-02
Publications
- Results Joy MS, Gipson DS, Dike M, Powell L, Thompson A, Vento S, Eddy A, Fogo AB, Kopp JB, Cattran D, Trachtman H. Phase I trial of rosiglitazone in FSGS: I. Report of the FONT Study Group. Clin J Am Soc Nephrol. 2009 Jan;4(1):39-47. doi: 10.2215/CJN.02310508. Epub 2008 Dec 10.
- Results Trachtman H, Vento S, Herreshoff E, Radeva M, Gassman J, Stein DT, Savin VJ, Sharma M, Reiser J, Wei C, Somers M, Srivastava T, Gipson DS. Efficacy of galactose and adalimumab in patients with resistant focal segmental glomerulosclerosis: report of the font clinical trial group. BMC Nephrol. 2015 Jul 22;16:111. doi: 10.1186/s12882-015-0094-5.
- Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.
- Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
- Trachtman H, Vento S, Gipson D, Wickman L, Gassman J, Joy M, Savin V, Somers M, Pinsk M, Greene T. Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design. BMC Nephrol. 2011 Feb 10;12:8. doi: 10.1186/1471-2369-12-8.
- Joy MS, Gipson DS, Powell L, MacHardy J, Jennette JC, Vento S, Pan C, Savin V, Eddy A, Fogo AB, Kopp JB, Cattran D, Trachtman H. Phase 1 trial of adalimumab in Focal Segmental Glomerulosclerosis (FSGS): II. Report of the FONT (Novel Therapies for Resistant FSGS) study group. Am J Kidney Dis. 2010 Jan;55(1):50-60. doi: 10.1053/j.ajkd.2009.08.019. Epub 2009 Nov 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 24 mg/m2 | Subcutaneous |
| Subject | Galactose | Diagnostic / imaging agent | 0.2 g/kg | Oral |
| Comparator | Atorvastatin | Small molecule | 10 mg | Oral |
| Comparator | Atorvastatin | Small molecule | 20 mg | Oral |
| Comparator | LISINOPRIL ANHYDROUS | Small molecule | 10 mg | Oral |
| Comparator | LISINOPRIL ANHYDROUS | Small molecule | 20 mg | Oral |
| Comparator | Losartan | Other / unclassified | 25 mg | Oral |
| Comparator | Losartan | Other / unclassified | 50 mg | Oral |