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

Phase 1

Terminated

• Conditions: Focal Segmental Glomerulosclerosis
• Interventions: Drug: FG-3019

• Registration Number: NCT00782561
• Lead Sponsor: FibroGen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-31
• Primary Completion: 2009-06-18
• Study Completion: 2009-06-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FG-3019	FG-3019	FG-3019 5 mg/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Standard plasma and urinary PK parameters	32 weeks