Clincosm LogoSign in Get a demo

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

Sponsor
FibroGen (Industry)
Overall Status
Terminated
CT.gov ID
NCT00782561
Collaborator
(none)
2
Enrollment
3
Locations
1
Arm
14.6
Actual Duration (Months)
0.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Apr 1, 2008
Actual Primary Completion Date :
Jun 18, 2009
Actual Study Completion Date :
Jun 18, 2009

Arms and Interventions

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

Outcome Measures

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 [32 weeks]

Secondary Outcome Measures

  1. Standard plasma and urinary PK parameters [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 [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 New Hyde Park New York United States 11040
2 Chapel Hill North Carolina United States 27599-7155
3 Columbus Ohio United States 43205

Sponsors and Collaborators

  • FibroGen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
FibroGen
ClinicalTrials.gov Identifier:
NCT00782561
Other Study ID Numbers:
  • FGCL-MC3019-026
First Posted:
Oct 31, 2008
Last Update Posted:
Jul 31, 2019
Last Verified:
Jul 1, 2019
Keywords provided by FibroGen
steroid resistant focal segmental glomerulosclerosis
FSGS
adolescent focal segmental glomerulosclerosis
focal segmental glomerulosclerosis
Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental

Study Results

No Results Posted as of Jul 31, 2019