Clinical Trial Details

NCT ID: NCT03263091
Date Last Changed: October 2, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of FG-4592 and Placebo to evaluate Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)

Research Study Title

A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

Purpose

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
FibroGen
Duration
18 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Key Inclusion Criteria:

  • Diagnosis of primary MDS classified as very low, low or intermediate risk with < 5% blasts of > = 16 weeks duration

  • RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization

  • ESA use of less than 28 days and no ESA within the 12 weeks prior to randomization

  • Pre-transfusion hemoglobin of < = 10 g/dL,

  • ECOG of 0-1 at screen

Key Exclusion Criteria:

  • Diagnosis of secondary MDS

  • Significant myelofibrosis ( > 2+fibrosis)

  • MDS associated with 5q(del) abnormality

  • Screen serum erythropoietin level > 400 mIU/mL,

  • Clinically significant anemia due to non-MDS etiologies

Site Locations (12)

Country State City Zip Facility and Contact
United States California Alhambra 91801 Investigational Site
United States California Irvine 92604 Investigational Site
United States California Laguna Hills 92653 Investigational Site
United States California Los Angeles 90095 Investigational Site
United States California Los Angeles 91326 Investigational Site
United States California Pasadena 91105 Investigational Site
United States California Santa Rosa 95403 Investigational Site
United States California Torrance 90505 Investigational Site
United States California Valencia 91355 Investigational Site
United States California Ventura 93003 Investigational Site
United States California Westlake Village 91361 Investigational Site
United States Ohio Canton 44718 Investigational Site

Contact

Charles Bradley, PhD
1-415-978-1672
E-mail:

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