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

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00782561

Enrollment

Registered

2008-10-31

Start date

2008-04-30

Completion date

2009-06-18

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Segmental Glomerulosclerosis

Keywords

steroid resistant focal segmental glomerulosclerosis, FSGS, adolescent focal segmental glomerulosclerosis, focal segmental glomerulosclerosis

Brief 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).

Interventions

DRUGFG-3019

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 64 Years

Healthy volunteers

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

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%

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications	32 weeks

Secondary

Measure	Time frame
Standard plasma and urinary PK parameters	32 weeks
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	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026