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
1 other identifier
interventional
2
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2009
CompletedJuly 31, 2019
July 1, 2019
1.2 years
October 27, 2008
July 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
FG-3019
EXPERIMENTALFG-3019 5 mg/kg
Interventions
Eligibility Criteria
You may qualify if:
- Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
- Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
- Age less than or equal to 2 years old at onset of proteinuria
- First morning urine protein/creatinine ratio (U p/c) \>1 gm/gm
- Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2
You may not qualify if:
- Non-FSGS renal disease other than benign cyst; or secondary FSGS
- History of organ transplantation
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
- 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)
- 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
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 times the upper limit of normal
- Hematocrit \< 30%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyntra Biolead
Study Sites (3)
Unknown Facility
New Hyde Park, New York, 11040, United States
Unknown Facility
Chapel Hill, North Carolina, 27599-7155, United States
Unknown Facility
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2008
First Posted
October 31, 2008
Study Start
April 1, 2008
Primary Completion
June 18, 2009
Study Completion
June 18, 2009
Last Updated
July 31, 2019
Record last verified: 2019-07