A Phase 1 interventional study of FG-3019 and FG-3019 in Diabetes Mellitus and Diabetic Nephropathy, sponsored by FibroGen. Completed at 18 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by FibroGen · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 38 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →FibroGen is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: FG-3019
FG-3019 5 mg/kg
Drug: FG-3019
FG-3019 10 mg/kg
Drug: FG-3019
Placebo every 2 weeks IV for all infusions
FG-3019 5 mg/kg every 2 weeks IV for all infusions
FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71
Safety and tolerability of FG-3019
Time frame: 34 weeks
Pharmacokinetic parameters
Time frame: 34 weeks
Change from baseline in first morning urinary albumin creatinine ratio (ACR)
Time frame: 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg)
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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FibroGen