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Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Lower Risk MDS

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: NCT03303066
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
FibroGen

Brief Summary:
The objective of this study to evaluate the efficacy and safety of FG-4592 for the treatment of anemia in Chinese subjects with lower risk MDS.

Condition or disease Intervention/treatment Phase
Primary MDS Classified as Very Low, Low or Intermediate Risk With <5% Blasts Drug: FG-4592 Drug: Placebo Phase 2 Phase 3

Detailed Description:
This is a Phase 2/3 trial with sequential Phase 2 and Phase 3 components. In each, there is an up to 4 weeks screen period followed by a treatment period of 26 weeks and a 4 week follow up period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: FG-4592 (Open Label, Double-blind, Three times a week)
Fixed starting doses (different doses for lower body weight & higher body weight); dose adjustments to hemoglobin levels are allowed during the study.
Drug: FG-4592
Oral
Other Names:
  • Roxadustat
  • AZD9941

Placebo Comparator: Placebo (Double-blind, Three times a week)
Fixed starting doses (different doses for lower body weight & higher body weight); dose adjustments to hemoglobin levels are allowed during the study.
Drug: Placebo
Oral




Primary Outcome Measures :
  1. Proportion of subjects with a hemoglobin response to FG-4592 without transfusion [ Time Frame: 26 weeks ]
    Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance and reducing the number of red blood cell packs transfused in 26 weeks in comparison to baseline


Secondary Outcome Measures :
  1. Evaluate the incidence of treatment emergent adverse events and tolerability of roxadustat [ Time Frame: 30 weeks ]
    Adverse events, serious adverse events, vital signs, electrocardiograms, blood pressure, heart rate, and physical exams

  2. Number (%) of subjects with hemoglobin increase ≥ 1.5 g/dL from baseline [ Time Frame: 26 weeks ]
    Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction in 26 weeks in comparison to baseline

  3. Time to first hemoglobin response [ Time Frame: 26 weeks ]
    Impact of roxadustat (FG-4592) in achieving hemoglobin correction in 26 weeks in comparison to baseline

  4. Change from baseline in hemoglobin in Week 25 to 27 [ Time Frame: 2 weeks ]
    Impact of roxadustat (FG-4592) on hemoglobin correction and maintenance in Week 25 to 27 in comparison to baseline

  5. Proportion of subjects with mean Hb ≥ 10.0 g/dL [ Time Frame: 30 weeks ]
    Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance in comparison to baseline

  6. Incidence of transfusions over the treatment period [ Time Frame: 26 weeks ]
    Impact of roxadustat (FG-4592) in the number of red blood cell packs transfused in 26 weeks in comparison to baseline

  7. Effect of roxadustat on quality of life measured by FACT-An and FACIT-F [ Time Frame: 30 weeks ]
    Change in raw score from baseline as measured by FACT-An and FACIT-F


Other Outcome Measures:
  1. Change from baseline to maximum hemoglobin level [ Time Frame: 30 weeks ]
    Impact of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance in comparison to baseline

  2. Time to maximum hemoglobin increase [ Time Frame: 26 weeks ]
    Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction in 26 weeks in comparison to baseline

  3. Duration of transfusion independence [ Time Frame: 30 weeks ]
    Evaluate transfusion independence by measuring the number of red blood cell packs transfused throughout the course of the study in comparison to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (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 of >= 4 weeks duration
  • Screening Hb <10 g/dL and ≥6g/dL
  • Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
  • ESA-naïve (less than 4 weeks of ESA treatment in total, and not within 30 days of Day 1)
  • ECOG of 0-2 at screen

Key Exclusion Criteria:

  • Diagnosis of secondary MDS
  • Significant myelofibrosis (>2+fibrosis)
  • Any prior therapy with antithymocyte globulin, azacitidine, or decitabine. Or Prior therapy with cyclosporine, thalidomide , or lenalidomide within 12 weeks prior to Day
  • Screen serum erythropoietin level of >500 mIU/mL
  • Clinically significant anemia due to non-MDS etiologies

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): NCT03303066


Contacts
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Contact: Chunrong Wang, MD 86 21 68810683 ext 815 crwang@fibrogen.cn
Contact: Xiaoning Cai 86 18515307508 xcai@fibrogen.cn

Locations
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China
Investigational Site Recruiting
Suzhou, China
Sponsors and Collaborators
FibroGen
AstraZeneca
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT03303066    
Other Study ID Numbers: FGCL-4592-813
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

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