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

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Focal Segmental Glomerulosclerosis

In brief

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

Key facts

Study ID

NCT01665391

Run by

Genzyme, a Sanofi Company

People needed

36

Starts

2012-08-01

Expected to finish

2014-11-01

Last updated by the study team

2015-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Investigational Site Number 4008 — Birmingham, Alabama, United States
• Investigational Site Number 4029 — Phoenix, Arizona, United States
• Investigational Site Number 4009 — San Francisco, California, United States
• Investigational Site Number 4023 — Stanford, California, United States
• Investigational Site Number 4005 — Atlanta, Georgia, United States
• Investigational Site Number 4019 — Springfield, Illinois, United States
• Investigational Site Number 4004 — Baltimore, Maryland, United States
• Investigational Site Number 4002 — Bethesda, Maryland, United States
• Investigational Site Number 4022 — Boston, Massachusetts, United States
• Investigational Site Number 4012 — Ann Arbor, Michigan, United States
• Investigational Site Number 4025 — Detroit, Michigan, United States
• Investigational Site Number 4006 — Rochester, Minnesota, United States
• Investigational Site Number 4024 — St Louis, Missouri, United States
• Investigational Site Number 4016 — New York, New York, United States
• Investigational Site Number 4003 — New York, New York, United States
• Investigational Site Number 4014 — Rosedale, New York, United States
• Investigational Site Number 4018 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 4001 — Chattanooga, Tennessee, United States
• Investigational Site Number 4020 — Dallas, Texas, United States
• Investigational Site Number 4027 — Houston, Texas, United States
• Investigational Site Number 4013 — Seattle, Washington, United States
• Investigational Site Number 4104 — Porto Alegre, Brazil
• Investigational Site Number 4302 — Aachen, Germany
• Investigational Site Number 4301 — Düsseldorf, Germany
• Investigational Site Number 4304 — Hamburg, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.