A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)
NCT ID: NCT01665391
Last Updated: 2015-08-26
Study Results
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Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2012-08-31
2014-11-30
Brief Summary
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* to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo
* to compare the safety profile of patients treated with fresolimumab versus placebo
The secondary objectives are as follows:
* To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo
* To evaluate fresolimumab dose-dependent reduction in proteinuria
* To compare the change in renal function (estimated glomerular filtration rate \[eGFR\]) in patients treated with fresolimumab versus placebo
* To evaluate the multiple-dose pharmacokinetics of fresolimumab
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fresolimumab 1 mg/kg total body weight
fresolimumab
1 mg/kg total body weight administered intravenous (IV)
fresolimumab 4 mg/kg total body weight
fresolimumab
4 mg/kg total body weight administered intravenous (IV)
Placebo
Placebo
Placebo administered to match active treatment group
Interventions
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fresolimumab
1 mg/kg total body weight administered intravenous (IV)
fresolimumab
4 mg/kg total body weight administered intravenous (IV)
Placebo
Placebo administered to match active treatment group
Eligibility Criteria
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Inclusion Criteria
* The patient has an eGFR ≥ 30 mL/min/1.73 m2
* The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg creatinine
* In the opinion of the Investigator, the patient has steroid-resistant FSGS. The patient must have been treated for FSGS with a course of high-dose steroid therapy for a minimum of 4 weeks
* The patient has been treated with an ACEi (angiotensin converting enzyme inhibitor) and/or ARB (angiotensin receptor blocker) at a stable dose for a minimum of 4 weeks prior to Visit 2 (treatment start)
Exclusion Criteria
* The patient has been taking prednisone at a dose \> 10 mg/day (or equivalent dose of an alternative glucocorticoid) within 4 weeks prior to Visit 1 (Screening Visit).
* The patient has received any other systemically administered immunosuppressive drugs (other than glucocorticoids) within 8 weeks prior to Visit 1.
* The patient has received rituximab within 6 months prior to Visit 1.
* The patient has a history of organ transplantation.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Investigational Site Number 4008
Birmingham, Alabama, United States
Investigational Site Number 4029
Phoenix, Arizona, United States
Investigational Site Number 4009
San Francisco, California, United States
Investigational Site Number 4023
Stanford, California, United States
Investigational Site Number 4005
Atlanta, Georgia, United States
Investigational Site Number 4019
Springfield, Illinois, United States
Investigational Site Number 4004
Baltimore, Maryland, United States
Investigational Site Number 4002
Bethesda, Maryland, United States
Investigational Site Number 4022
Boston, Massachusetts, United States
Investigational Site Number 4012
Ann Arbor, Michigan, United States
Investigational Site Number 4025
Detroit, Michigan, United States
Investigational Site Number 4006
Rochester, Minnesota, United States
Investigational Site Number 4024
St Louis, Missouri, United States
Investigational Site Number 4016
New York, New York, United States
Investigational Site Number 4003
New York, New York, United States
Investigational Site Number 4014
Rosedale, New York, United States
Investigational Site Number 4018
Philadelphia, Pennsylvania, United States
Investigational Site Number 4001
Chattanooga, Tennessee, United States
Investigational Site Number 4020
Dallas, Texas, United States
Investigational Site Number 4027
Houston, Texas, United States
Investigational Site Number 4013
Seattle, Washington, United States
Investigational Site Number 4104
Porto Alegre, , Brazil
Investigational Site Number 4302
Aachen, , Germany
Investigational Site Number 4301
Düsseldorf, , Germany
Investigational Site Number 4304
Hamburg, , Germany
Investigational Site Number 4401
Bari, , Italy
Investigational Site Number 4404
Bergamo, , Italy
Investigational Site Number 4403
Montichiari, , Italy
Investigational Site Number 4405
Reggio Calabria, , Italy
Investigational Site Number 4503
Barcelona, , Spain
Investigational Site Number 4504
Madrid, , Spain
Investigational Site Number 4502
Madrid, , Spain
Countries
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References
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Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
Other Identifiers
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2010-019545-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1139-9082
Identifier Type: OTHER
Identifier Source: secondary_id
DRI12792
Identifier Type: OTHER
Identifier Source: secondary_id
GC1008FSGS03110
Identifier Type: -
Identifier Source: org_study_id
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