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: April 1, 2014
Last verified: April 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: June 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
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: April 1, 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 April 17, 2014