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Trial record 1 of 1 for:    FGCL-4592-082 | MDS | Leipzig, Germany
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Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263091
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
FibroGen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts) Drug: FG-4592 Drug: Placebo Phase 3

Detailed Description:
This study includes an Open-Label and a Double-Blind component. In each, there is an up to 42 days screen period followed by a treatment period of 52 weeks and a 4 week end of treatment assessment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: FG-4592 (Open Label, Double-blind, Three times a week)
Weight-based starting doses; dose adjustments to hemoglobin levels are allowed during the study.
 Drug: FG-4592
Oral
Other Names:
  • Roxadustat
  • ASP1517
  • AZD9941
Placebo Comparator: Placebo (Double-blind, Three times a week)
Weight-based starting doses; dose adjustments to hemoglobin levels are allowed during the study.
 Drug: Placebo
Oral


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of roxadustat (FG-4592) to achieve transfusion independence ≥ 56 consecutive days [ Time Frame: 28 weeks ]
    Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance and reducing the number of red blood cell packs transfused in 28 weeks in comparison to baseline


Secondary Outcome Measures :
  1. Evaluate the incidence of treatment emergent adverse events of roxadustat [ Time Frame: 52 weeks ]
    Adverse events, serious adverse events, vital signs, electrocardiograms, blood pressure, heart rate, and physical exams

  2. Evaluate the impact of roxadustat on RBC transfusion requirements [ Time Frame: 52 weeks ]
    Impact of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance and reducing the number of red blood cell packs transfused throughout the course of the study in comparison to baseline

  3. Effect of roxadustat on quality of life parameters, as measured by PROMIS and EQ-5D-5L assessment [ Time Frame: 52 weeks ]
    Change in raw score from baseline in Physical Function (PF) and Fatigue score as measured by Patient-Reported Outcome Measurement Information System (PROMIS). And change in raw score from baseline in the EuroQol Quality of Life Five Dimensional Five Level Health Questionnaire (EQ-5D-5L) assessment.

  4. Evaluate transfusion independence ≥ 56 consecutive days [ Time Frame: 52 weeks ]
    Evaluate transfusion independence by measuring the number of red blood cell packs transfused throughout the course of the study in comparison to baseline


Other Outcome Measures:
  1. Duration of transfusion independence [ Time Frame: 52 weeks ]
    Evaluate transfusion independence by measuring the number of red blood cell packs transfused throughout the course of the study in comparison to baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts. There is no minimum time from diagnosis except to allow for proper IPSS-R classification to be made, and to show transfusion dependence.
  • 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
  • No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization
  • Pre-transfusion hemoglobin of <= 10 g/dL,
  • ECOG of 0-2 at screen
  • History of cured malignancy with no evidence of recurrence for a least 3 years are eligible

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263091


Contacts
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Contact: Charles Bradley, PhD 1-415-978-1672 082MDSstudy@fibrogen.com
Contact: Katharina Modelska, MD,PhD 415-978-1803 082MDSstudy@fibrogen.com

Locations
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Sponsors and Collaborators
FibroGen
AstraZeneca
Investigators
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Study Chair: K. Peony Yu, MD FibroGen
More Information
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT03263091    
Other Study ID Numbers: FGCL-4592-082
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FibroGen:
Myelodysplastic Syndromes
Anemia
Hemoglobin (Hb)
Low Risk Myelodysplastic Syndrome
Low Risk MDS
Additional relevant MeSH terms:
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Anemia
Myelodysplastic Syndromes
Hematologic Diseases
Bone Marrow Diseases