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

This study has been terminated.
Sponsor:
Information provided by:
FibroGen
ClinicalTrials.gov Identifier:
NCT00782561
First received: October 27, 2008
Last updated: July 14, 2009
Last verified: July 2009

October 27, 2008
July 14, 2009
April 2008
June 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00782561 on ClinicalTrials.gov Archive Site
  • Standard plasma and urinary PK parameters [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Focal Segmental Glomerulosclerosis
Drug: FG-3019
FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks
Experimental: FG-3019
FG-3019 5 mg/kg
Intervention: Drug: FG-3019
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
March 2011
June 2010   (final data collection date for primary outcome measure)

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%
Both
12 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00782561
FGCL-MC3019-026
No
Claro Arzadon, Clinical Research Associate, FibroGen, Inc.
FibroGen
Not Provided
Not Provided
FibroGen
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP