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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01665391
First received: August 13, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Primary Focal Segmental Glomerulosclerosis
Drug: fresolimumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Number of patients reporting adverse events (AEs), serious adverse events (SAEs), and medical events of interest (MEOIs) [ Time Frame: Up to Day 112 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of patients achieving CR in Up/c ratio [ Time Frame: Up to Day 112 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving PR in Up/c ratio [ Time Frame: Up to Day 112 ] [ Designated as safety issue: No ]
  • Change from baseline in Up/c ratio and urinary protein excretion rate [ Time Frame: Up to Day 112 ] [ Designated as safety issue: No ]
  • Time to first PR or CR [ Time Frame: Up to Day 112 ] [ Designated as safety issue: No ]
  • Change from baseline in eGFR (estimated glomerular filtration rate) [ Time Frame: Up to Day 112 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate) [ Time Frame: Up to Day 112 ] [ Designated as safety issue: No ]
  • Pharmacokinetics as measured by Cmax, tmax, AUC (area under curve) 0-last, C trough, t 1/2z [ Time Frame: Up to Day 252 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665391

  Show 32 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01665391     History of Changes
Other Study ID Numbers: GC1008FSGS03110, 2010-019545-25, U1111-1139-9082
Study First Received: August 13, 2012
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
Spain: Ministry of Health
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014