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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019545-25 | EudraCT Number | ||
| U1111-1139-9082 | Other Identifier | World Health Organization Universal Trial Number (UTN) | |
| DRI12792 | Other Identifier | Sanofi |
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The primary objectives of this trial are as follows:
The secondary objectives are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fresolimumab 1 mg/kg total body weight | Experimental |
| |
| fresolimumab 4 mg/kg total body weight | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fresolimumab | Drug | 1 mg/kg total body weight administered intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) | Up to Day 112 | |
| Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs) | Up to Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Up/c ratio and urinary protein excretion rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 4008 | Birmingham | Alabama | 35205 | United States | ||
| Investigational Site Number 4029 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224732 | Derived | 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. |
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| fresolimumab | Drug | 4 mg/kg total body weight administered intravenous (IV) |
|
| Placebo | Drug | Placebo administered to match active treatment group |
|
| Up to Day 112 |
| Time to first PR or CR | Up to Day 112 |
| Change from baseline in eGFR (estimated glomerular filtration rate) | 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 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Investigational Site Number 4009 | San Francisco | California | 94143 | United States |
| Investigational Site Number 4023 | Stanford | California | 94305 | United States |
| Investigational Site Number 4005 | Atlanta | Georgia | 30322 | United States |
| Investigational Site Number 4019 | Springfield | Illinois | 01107 | United States |
| Investigational Site Number 4004 | Baltimore | Maryland | 21287 | United States |
| Investigational Site Number 4002 | Bethesda | Maryland | 20892 | United States |
| Investigational Site Number 4022 | Boston | Massachusetts | 02115 | United States |
| Investigational Site Number 4012 | Ann Arbor | Michigan | 48109 | United States |
| Investigational Site Number 4025 | Detroit | Michigan | 48202 | United States |
| Investigational Site Number 4006 | Rochester | Minnesota | 55905 | United States |
| Investigational Site Number 4024 | St Louis | Missouri | 63110 | United States |
| Investigational Site Number 4016 | New York | New York | 10029 | United States |
| Investigational Site Number 4003 | New York | New York | 10032 | United States |
| Investigational Site Number 4014 | Rosedale | New York | 11422 | United States |
| Investigational Site Number 4018 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Site Number 4001 | Chattanooga | Tennessee | 37404 | United States |
| Investigational Site Number 4020 | Dallas | Texas | 75390 | United States |
| Investigational Site Number 4027 | Houston | Texas | 77030 | United States |
| Investigational Site Number 4013 | Seattle | Washington | 98195 | United States |
| Investigational Site Number 4104 | Porto Alegre | 90035 003 | Brazil |
| Investigational Site Number 4302 | Aachen | 52074 | Germany |
| Investigational Site Number 4301 | Düsseldorf | 40225 | Germany |
| Investigational Site Number 4304 | Hamburg | 20246 | Germany |
| Investigational Site Number 4401 | Bari | 70124 | Italy |
| Investigational Site Number 4404 | Bergamo | 24127 | Italy |
| Investigational Site Number 4403 | Montichiari | 25018 | Italy |
| Investigational Site Number 4405 | Reggio Calabria | 89124 | Italy |
| Investigational Site Number 4503 | Barcelona | 08025 | Spain |
| Investigational Site Number 4504 | Madrid | 28040 | Spain |
| Investigational Site Number 4502 | Madrid | 28041 | Spain |
| ID | Term |
|---|---|
| C560928 | fresolimumab |
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