Overview

This trial is active, not recruiting.

Condition primary focal segmental glomerulosclerosis
Treatments fresolimumab, placebo
Phase phase 2
Sponsor Genzyme, a Sanofi Company
Start date August 2012
End date June 2014
Trial size 36 participants
Trial identifier NCT01665391, 2010-019545-25, GC1008FSGS03110, U1111-1139-9082

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
fresolimumab
1 mg/kg total body weight administered intravenous (IV)
(Experimental)
fresolimumab
4 mg/kg total body weight administered intravenous (IV)
(Placebo Comparator)
placebo
Placebo administered to match active treatment group

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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 (area under curve) 0-last, C trough, t 1/2z
time frame: Up to Day 252

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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) Exclusion Criteria: - 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Sanofi.