A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)
- Conditions
- Primary Focal Segmental Glomerulosclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01665391
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
The primary objectives of this trial are as follows:
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- The patient's renal biopsy is consistent with the diagnosis of primary Focal Segmental Glomerulosclerosis (FSGS) including all histological subtypes.
- 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)
- The patient has FSGS which in the Investigator's opinion is secondary to another condition
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - fresolimumab 1 mg/kg total body weight fresolimumab - fresolimumab 4 mg/kg total body weight fresolimumab -
- Primary Outcome Measures
Name Time Method Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs) Up to Day 112 Percentage of patients achieving partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) Up to Day 112
- Secondary Outcome Measures
Name Time Method Percentage of patients achieving CR in Up/c ratio Up to Day 112 Percentage of patients achieving PR in Up/c ratio Up to Day 112 Change from baseline in eGFR (estimated glomerular filtration rate) Up to Day 112 Change from baseline in Up/c ratio and urinary protein excretion rate Up to Day 112 Time to first PR or CR Up to Day 112 Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate) Up to Day 112 Mean Fresolimumab serum concentration at each sample collection time point Up to Day 252
Trial Locations
- Locations (32)
Investigational Site Number 4009
🇺🇸San Francisco, California, United States
Investigational Site Number 4004
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 4005
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 4003
🇺🇸New York, New York, United States
Investigational Site Number 4019
🇺🇸Springfield, Illinois, United States
Investigational Site Number 4002
🇺🇸Bethesda, Maryland, United States
Investigational Site Number 4018
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 4008
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 4016
🇺🇸New York, New York, United States
Investigational Site Number 4022
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 4025
🇺🇸Detroit, Michigan, United States
Investigational Site Number 4006
🇺🇸Rochester, Minnesota, United States
Investigational Site Number 4027
🇺🇸Houston, Texas, United States
Investigational Site Number 4404
🇮🇹Bergamo, Italy
Investigational Site Number 4020
🇺🇸Dallas, Texas, United States
Investigational Site Number 4503
🇪🇸Barcelona, Spain
Investigational Site Number 4504
🇪🇸Madrid, Spain
Investigational Site Number 4405
🇮🇹Reggio Calabria, Italy
Investigational Site Number 4401
🇮🇹Bari, Italy
Investigational Site Number 4304
🇩🇪Hamburg, Germany
Investigational Site Number 4502
🇪🇸Madrid, Spain
Investigational Site Number 4403
🇮🇹Montichiari, Italy
Investigational Site Number 4024
🇺🇸St Louis, Missouri, United States
Investigational Site Number 4012
🇺🇸Ann Arbor, Michigan, United States
Investigational Site Number 4302
🇩🇪Aachen, Germany
Investigational Site Number 4014
🇺🇸Rosedale, New York, United States
Investigational Site Number 4013
🇺🇸Seattle, Washington, United States
Investigational Site Number 4104
🇧🇷Porto Alegre, Brazil
Investigational Site Number 4023
🇺🇸Stanford, California, United States
Investigational Site Number 4301
🇩🇪Düsseldorf, Germany
Investigational Site Number 4029
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 4001
🇺🇸Chattanooga, Tennessee, United States