A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

Primary Focal Segmental Glomerulosclerosis Clinical Trial

— FSGS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665391
• Other study ID #: GC1008FSGS03110
• Secondary ID: 2010-019545-25U1
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2012
• Last updated: August 12, 2015
• Start date: August 2012
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulosclerosis, Focal Segmental
• Primary Focal Segmental Glomerulosclerosis

Intervention

Drug:
• fresolimumab
1 mg/kg total body weight administered intravenous (IV)
• fresolimumab
4 mg/kg total body weight administered intravenous (IV)
• Placebo
Placebo administered to match active treatment group

Locations

Country	Name	City	State
Brazil	Investigational Site Number 4104	Porto Alegre
Germany	Investigational Site Number 4302	Aachen
Germany	Investigational Site Number 4301	Düsseldorf
Germany	Investigational Site Number 4304	Hamburg
Italy	Investigational Site Number 4401	Bari
Italy	Investigational Site Number 4404	Bergamo
Italy	Investigational Site Number 4403	Montichiari
Italy	Investigational Site Number 4405	Reggio Calabria
Spain	Investigational Site Number 4503	Barcelona
Spain	Investigational Site Number 4502	Madrid
Spain	Investigational Site Number 4504	Madrid
United States	Investigational Site Number 4012	Ann Arbor	Michigan
United States	Investigational Site Number 4005	Atlanta	Georgia
United States	Investigational Site Number 4004	Baltimore	Maryland
United States	Investigational Site Number 4002	Bethesda	Maryland
United States	Investigational Site Number 4008	Birmingham	Alabama
United States	Investigational Site Number 4022	Boston	Massachusetts
United States	Investigational Site Number 4001	Chattanooga	Tennessee
United States	Investigational Site Number 4020	Dallas	Texas
United States	Investigational Site Number 4025	Detroit	Michigan
United States	Investigational Site Number 4027	Houston	Texas
United States	Investigational Site Number 4003	New York	New York
United States	Investigational Site Number 4016	New York	New York
United States	Investigational Site Number 4018	Philadelphia	Pennsylvania
United States	Investigational Site Number 4029	Phoenix	Arizona
United States	Investigational Site Number 4006	Rochester	Minnesota
United States	Investigational Site Number 4014	Rosedale	New York
United States	Investigational Site Number 4009	San Francisco	California
United States	Investigational Site Number 4013	Seattle	Washington
United States	Investigational Site Number 4019	Springfield	Illinois
United States	Investigational Site Number 4024	St Louis	Missouri
United States	Investigational Site Number 4023	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Brazil,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio)		Up to Day 112	No
Primary	Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs)		Up to Day 112	Yes
Secondary	Percentage of patients achieving CR in Up/c ratio		Up to Day 112	No
Secondary	Percentage of patients achieving PR in Up/c ratio		Up to Day 112	No
Secondary	Change from baseline in Up/c ratio and urinary protein excretion rate		Up to Day 112	No
Secondary	Time to first PR or CR		Up to Day 112	No
Secondary	Change from baseline in eGFR (estimated glomerular filtration rate)		Up to Day 112	No
Secondary	Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate)		Up to Day 112	No
Secondary	Mean Fresolimumab serum concentration at each sample collection time point		Up to Day 252	No