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
  Purpose

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).


Condition Intervention Phase
Focal Segmental Glomerulosclerosis
Drug: FG-3019
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: April 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FG-3019
FG-3019 5 mg/kg
Drug: FG-3019
FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782561

Locations
United States, New York
New Hyde Park, New York, United States, 11040
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7155
United States, Ohio
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: Claro Arzadon, Clinical Research Associate, FibroGen, Inc.
ClinicalTrials.gov Identifier: NCT00782561     History of Changes
Other Study ID Numbers: FGCL-MC3019-026
Study First Received: October 27, 2008
Last Updated: July 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by FibroGen:
steroid resistant focal segmental glomerulosclerosis
FSGS
adolescent focal segmental glomerulosclerosis
focal segmental glomerulosclerosis

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014