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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01665391
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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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

Condition or disease Intervention/treatment Phase
Primary Focal Segmental Glomerulosclerosis Drug: fresolimumab Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: fresolimumab 1 mg/kg total body weight Drug: fresolimumab
1 mg/kg total body weight administered intravenous (IV)
Experimental: fresolimumab 4 mg/kg total body weight Drug: fresolimumab
4 mg/kg total body weight administered intravenous (IV)
Placebo Comparator: Placebo Drug: Placebo
Placebo administered to match active treatment group


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs) [ Time Frame: Up to Day 112 ]

Secondary Outcome Measures :
  1. Percentage of patients achieving CR in Up/c ratio [ Time Frame: Up to Day 112 ]
  2. Percentage of patients achieving PR in Up/c ratio [ Time Frame: Up to Day 112 ]
  3. Change from baseline in Up/c ratio and urinary protein excretion rate [ Time Frame: Up to Day 112 ]
  4. Time to first PR or CR [ Time Frame: Up to Day 112 ]
  5. Change from baseline in eGFR (estimated glomerular filtration rate) [ Time Frame: Up to Day 112 ]
  6. Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate) [ Time Frame: Up to Day 112 ]
  7. Mean Fresolimumab serum concentration at each sample collection time point [ Time Frame: Up to Day 252 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665391


Locations
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Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01665391    
Other Study ID Numbers: GC1008FSGS03110
2010-019545-25 ( EudraCT Number )
U1111-1139-9082 ( Other Identifier: World Health Organization Universal Trial Number (UTN) )
DRI12792 ( Other Identifier: Sanofi )
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs