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

August 12, 2015 updated by: Genzyme, a Sanofi Company

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Porto Alegre, Brazil, 90035 003
        • Investigational Site Number 4104
  • Germany
      • Aachen, Germany, 52074
        • Investigational Site Number 4302
      • Düsseldorf, Germany, 40225
        • Investigational Site Number 4301
      • Hamburg, Germany, 20246
        • Investigational Site Number 4304
  • Italy
      • Bari, Italy, 70124
        • Investigational Site Number 4401
      • Bergamo, Italy, 24127
        • Investigational Site Number 4404
      • Montichiari, Italy, 25018
        • Investigational Site Number 4403
      • Reggio Calabria, Italy, 89124
        • Investigational Site Number 4405
  • Spain
      • Barcelona, Spain, 08025
        • Investigational Site Number 4503
      • Madrid, Spain, 28040
        • Investigational Site Number 4504
      • Madrid, Spain, 28041
        • Investigational Site Number 4502
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Investigational Site Number 4008
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Investigational Site Number 4029
    • California
      • San Francisco, California, United States, 94143
        • Investigational Site Number 4009
      • Stanford, California, United States, 94305
        • Investigational Site Number 4023
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Investigational Site Number 4005
    • Illinois
      • Springfield, Illinois, United States, 01107
        • Investigational Site Number 4019
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Investigational Site Number 4004
      • Bethesda, Maryland, United States, 20892
        • Investigational Site Number 4002
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Investigational Site Number 4022
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Investigational Site Number 4012
      • Detroit, Michigan, United States, 48202
        • Investigational Site Number 4025
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Investigational Site Number 4006
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Investigational Site Number 4024
    • New York
      • New York, New York, United States, 10029
        • Investigational Site Number 4016
      • New York, New York, United States, 10032
        • Investigational Site Number 4003
      • Rosedale, New York, United States, 11422
        • Investigational Site Number 4014
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigational Site Number 4018
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigational Site Number 4001
    • Texas
      • Dallas, Texas, United States, 75390
        • Investigational Site Number 4020
      • Houston, Texas, United States, 77030
        • Investigational Site Number 4027
    • Washington
      • Seattle, Washington, United States, 98195
        • Investigational Site Number 4013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo administered to match active treatment group
Experimental: fresolimumab 1 mg/kg total body weight
Drug: fresolimumab
1 mg/kg total body weight administered intravenous (IV)
Drug: fresolimumab
4 mg/kg total body weight administered intravenous (IV)
Experimental: fresolimumab 4 mg/kg total body weight
Drug: fresolimumab
1 mg/kg total body weight administered intravenous (IV)
Drug: fresolimumab
4 mg/kg total body weight administered intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Up to Day 112

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients achieving CR in Up/c ratio
Time Frame: Up to Day 112
Up to Day 112
Percentage of patients achieving PR in Up/c ratio
Time Frame: Up to Day 112
Up to Day 112
Change from baseline in Up/c ratio and urinary protein excretion rate
Time Frame: Up to Day 112
Up to Day 112
Time to first PR or CR
Time Frame: Up to Day 112
Up to Day 112
Change from baseline in eGFR (estimated glomerular filtration rate)
Time Frame: Up to Day 112
Up to Day 112
Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate)
Time Frame: Up to Day 112
Up to Day 112
Mean Fresolimumab serum concentration at each sample collection time point
Time Frame: Up to Day 252
Up to Day 252

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GC1008FSGS03110
  • 2010-019545-25 (EudraCT Number)
  • U1111-1139-9082 (Other Identifier: World Health Organization Universal Trial Number (UTN))
  • DRI12792 (Other Identifier: Sanofi)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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