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

NCT ID: NCT00782561

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-06-18

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).

Conditions

Focal Segmental Glomerulosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FG-3019

FG-3019 5 mg/kg

Group Type: EXPERIMENTAL

FG-3019

Intervention Type: DRUG

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

Interventions

FG-3019

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

Intervention Type: DRUG

Eligibility 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%

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FibroGen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New Hyde Park, New York, United States

Chapel Hill, North Carolina, United States

Columbus, Ohio, United States

Countries

United States

Other Identifiers

FGCL-MC3019-026

Identifier Type: -

Identifier Source: org_study_id