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A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis

NCT01665391•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (32)

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

Key Dates

Start Date

August 1, 2012

Primary Completion Date

June 1, 2014

Completion Date

November 1, 2014

Last Updated

August 26, 2015

Enrollment

ACTUAL participants

Conditions

Primary Focal Segmental Glomerulosclerosis

Interventions

fresolimumab

DRUG

fresolimumab

DRUG

Placebo

DRUG

Study of WAL0921 in Patients With Glomerular Kidney Diseases

NCT06466135

Diabetic NephropathiesPrimary Focal Segmental Glomerulosclerosis+3 more

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COMPLETEDPHASE2

Obinutuzumab in Primary FSGS

NCT04983888

Primary Focal Segmental Glomerulosclerosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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