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

Focal Segmental Glomerulosclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00782561
• Other study ID #: FGCL-MC3019-026
• Status: Terminated
• Phase: Phase 1
• Start date: April 2008
• Est. completion date: June 18, 2009

Study information

• Verified date: July 2019
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 18, 2009
• Est. primary completion date: June 18, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 64 Years

Eligibility

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%

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• Glomerulosclerosis, Focal Segmental

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Standard plasma and urinary PK parameters		32 weeks
Secondary	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