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TerminatedNCT00782561Updated Jul 31, 2019

Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)

A Phase 1 interventional study of FG-3019 in Focal Segmental Glomerulosclerosis, sponsored by FibroGen. Terminated at 3 sites in United States. Open to participants aged 12 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by FibroGen · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2008, registered Oct 2008).
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
12 Years to 64 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).

02

Conditions studied

  • Focal Segmental Glomerulosclerosis

Keywords

  • steroid resistant focal segmental glomerulosclerosis
  • FSGS
  • adolescent focal segmental glomerulosclerosis
  • focal segmental glomerulosclerosis
03

In context

Glomerulosclerosis, Focal Segmental

98 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 31 are open to participants now.

This study's enrollment of 2 is below the median of 32 across 69 interventional studies indexed under Glomerulosclerosis, Focal Segmental.

Browse Glomerulosclerosis, Focal Segmental studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
12 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
  2. Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
  3. Age less than or equal to 2 years old at onset of proteinuria
  4. First morning urine protein/creatinine ratio (U p/c) >1 gm/gm
  5. Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2

Exclusion criteria

Exclusion Criteria:

  1. Non-FSGS renal disease other than benign cyst; or secondary FSGS
  2. History of organ transplantation
  3. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
  4. History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)
  5. Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0
  6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal
  7. Hematocrit \< 30%
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    FG-3019

    FG-3019 5 mg/kg

    Drug: FG-3019

Interventions

  • DrugFG-3019

    FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications

    Time frame: 32 weeks

Secondary outcomes

  1. Standard plasma and urinary PK parameters

    Time frame: 32 weeks

  2. Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids

    Time frame: 8 weeks

07

Study locations

3 sites
  • New Hyde Park, New York 11040, United States
  • Chapel Hill, North Carolina 27599-7155, United States
  • Columbus, Ohio 43205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00782561
Lead sponsor
FibroGen
Responsible party
Sponsor
First posted
Oct 31, 2008
Start date
Apr 2008
Primary completion
Jun 18, 2009
Completion
Jun 18, 2009
Last update
Jul 31, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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