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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
1 mg/kg total body weight administered intravenous (IV)
4 mg/kg total body weight administered intravenous (IV)
Placebo administered to match active treatment group
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
Percentage of patients achieving partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio)
Time frame: Up to Day 112
Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs)
Time frame: Up to Day 112
Percentage of patients achieving CR in Up/c ratio
Time frame: Up to Day 112
Percentage of patients achieving PR in Up/c ratio
Time frame: Up to Day 112
Change from baseline in Up/c ratio and urinary protein excretion rate
Time frame: Up to Day 112
Time to first PR or CR
Time frame: Up to Day 112
Change from baseline in eGFR (estimated glomerular filtration rate)
Time frame: Up to Day 112
Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate)
Time frame: Up to Day 112
Mean Fresolimumab serum concentration at each sample collection time point
Time frame: Up to Day 252
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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
...and 22 more locations