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

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ClinicalTrials.gov Identifier: NCT00782561
Recruitment Status : Terminated
First Posted : October 31, 2008
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
FibroGen

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).

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Drug: FG-3019 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : April 2008
Actual Primary Completion Date : June 18, 2009
Actual Study Completion Date : June 18, 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Standard plasma and urinary PK parameters [ Time Frame: 32 weeks ]
  2. 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 ]


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Ages Eligible for Study:   12 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782561


Locations
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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
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT00782561    
Other Study ID Numbers: FGCL-MC3019-026
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Keywords provided by FibroGen:
steroid resistant focal segmental glomerulosclerosis
FSGS
adolescent focal segmental glomerulosclerosis
focal segmental glomerulosclerosis
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases