Clinical Trial: A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis
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 Summary:
Sponsor: Genzyme, a Sanofi Company
Current Primary Outcome:
- 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 ]
Original Primary Outcome:
- Number 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 ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- 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 ]
- Pharmacokinetics as measured by Cmax, tmax, AUC 0-last, C trough, t 1/2z [ Time Frame: Up to Day 252 ]
Information By: Sanofi
Dates:
Date Received: August 13, 2012
Date Started: August 2012
Date Completion:
Last Updated: August 12, 2015
Last Verified: August 2015