Skip to main content
OpenTrials
Completed

NCT Number: NCT01665391

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Focal Segmental Glomerulosclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number 4104, Porto Alegre, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fresolimumab

Drug

1 mg/kg total body weight administered intravenous (IV)

Placebo

Drug

Placebo administered to match active treatment group

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Acronym: FSGS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 15, 2012
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.