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

NCT01665391 | Completed Phase 2 DMC

• 4 other identifiers: GC1008FSGS031102010-019545-25U1111-1139-9082DRI12792
• Study Type: interventional
• Target: 36
• Locations: 5 countries
• Sites: 32

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

Conditions

Primary Focal Segmental Glomerulosclerosis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• 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

  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

Study Arms (3)

fresolimumab 1 mg/kg total body weight

EXPERIMENTAL

Drug: fresolimumab

fresolimumab 4 mg/kg total body weight

EXPERIMENTAL

Drug: fresolimumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

fresolimumab DRUG

1 mg/kg total body weight administered intravenous (IV)

fresolimumab 1 mg/kg total body weight

Placebo DRUG

Placebo administered to match active treatment group

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (32)

Investigational Site Number 4008

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 4029

Phoenix, Arizona, 85032, United States

Location

Investigational Site Number 4009

San Francisco, California, 94143, United States

Location

Investigational Site Number 4023

Stanford, California, 94305, United States

Location

Investigational Site Number 4005

Atlanta, Georgia, 30322, United States

Location

Investigational Site Number 4019

Springfield, Illinois, 01107, United States

Location

Investigational Site Number 4004

Baltimore, Maryland, 21287, United States

Location

Investigational Site Number 4002

Bethesda, Maryland, 20892, United States

Location

Investigational Site Number 4022

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 4012

Ann Arbor, Michigan, 48109, United States

Location

Investigational Site Number 4025

Detroit, Michigan, 48202, United States

Location

Investigational Site Number 4006

Rochester, Minnesota, 55905, United States

Location

Investigational Site Number 4024

St Louis, Missouri, 63110, United States

Location

Investigational Site Number 4016

New York, New York, 10029, United States

Location

Investigational Site Number 4003

New York, New York, 10032, United States

Location

Investigational Site Number 4014

Rosedale, New York, 11422, United States

Location

Investigational Site Number 4018

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 4001

Chattanooga, Tennessee, 37404, United States

Location

Investigational Site Number 4020

Dallas, Texas, 75390, United States

Location

Investigational Site Number 4027

Houston, Texas, 77030, United States

Location

Investigational Site Number 4013

Seattle, Washington, 98195, United States

Location

Investigational Site Number 4104

Porto Alegre, 90035 003, Brazil

Location

Investigational Site Number 4302

Aachen, 52074, Germany

Location

Investigational Site Number 4301

Düsseldorf, 40225, Germany

Location

Investigational Site Number 4304

Hamburg, 20246, Germany

Location

Investigational Site Number 4401

Bari, 70124, Italy

Location

Investigational Site Number 4404

Bergamo, 24127, Italy

Location

Investigational Site Number 4403

Montichiari, 25018, Italy

Location

Investigational Site Number 4405

Reggio Calabria, 89124, Italy

Location

Investigational Site Number 4503

Barcelona, 08025, Spain

Location

Investigational Site Number 4504

Madrid, 28040, Spain

Location

Investigational Site Number 4502

Madrid, 28041, Spain

Location

Related Publications (1)

• 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.

  PMID: 35224732 DERIVED

MeSH Terms

Interventions

fresolimumab

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

ES (3); US (21); IT (4); BR (1); DE (3)