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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00782561
• Date of registration: 27/10/2008
• Prospective Registration: No
• Primary sponsor: FibroGen
• Public title: Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)
• Scientific title: 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
• Date of first enrolment: April 2008
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00782561
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

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%



Age minimum: 12 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Intervention(s)

Drug: FG-3019

Primary Outcome(s)

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 Outcome(s)

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]

Standard plasma and urinary PK parameters [Time Frame: 32 weeks]

Secondary ID(s)

FGCL-MC3019-026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors