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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01665391
• Date of registration: 13/08/2012
• Prospective Registration: No
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS) FSGS
• Scientific title: A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis
• Date of first enrolment: August 2012
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01665391
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Brazil, Germany, Italy, Spain, United States

Contacts

• Name: Medical Monitor
• Affiliation: Genzyme, a Sanofi Company

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Focal Segmental Glomerulosclerosis

Intervention(s)

Drug: fresolimumab

Drug: Placebo

Primary Outcome(s)

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

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]

Secondary Outcome(s)

Change from baseline in eGFR (estimated glomerular filtration rate) [Time Frame: Up to Day 112]

Percentage of patients achieving PR in Up/c ratio [Time Frame: Up to Day 112]

Change from baseline in Up/c ratio and urinary protein excretion rate [Time Frame: Up to Day 112]

Percentage of patients achieving PR or CR with stable eGFR (estimated glomerular filtration rate) [Time Frame: Up to Day 112]

Mean Fresolimumab serum concentration at each sample collection time point [Time Frame: Up to Day 252]

Percentage of patients achieving CR in Up/c ratio [Time Frame: Up to Day 112]

Time to first PR or CR [Time Frame: Up to Day 112]

Secondary ID(s)

DRI12792

GC1008FSGS03110

2010-019545-25

U1111-1139-9082

Source(s) of Monetary Support

Please refer to primary and secondary sponsors