Skip to main content
OpenTrials
Completed

NCT Number: NCT03303066

Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)

The objective of this study to evaluate the efficacy FG-4592 for the treatment of anemia in Chinese participants with lower risk MDS.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndrome Myelodysplastic Syndromes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts (documented within 12 weeks prior to Day 1)
  • Screening Hb <10 g/dL and ≥6g/dL
  • Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
  • Erythropoiesis-stimulating agent (ESA)-naïve (not within 30 days of Day 1)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

Key Exclusion Criteria:

  • Diagnosis of secondary MDS
  • Significant myelofibrosis (>2+fibrosis)
  • Prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to Day 1
  • Baseline erythropoietin level of >400 units (U)/liter (L)
  • Clinically significant anemia due to non-MDS etiologies

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

FG-4592

Drug

Oral

Other names: Roxadustat, AZD9941

Placebo

Drug

Oral

Primary outcomes

  1. Percentage of Participants With a Hemoglobin (Hb) Response to FG-4592 Without Transfusion

    Time frame: 26 weeks

    Hemoglobin response to FG-4592 is defined as an increase in mean Hb of ≥1.0 grams (g)/deciliter (dL) from baseline within any 8-week period during the study without transfusion.

Secondary outcomes

  1. Number of Participants With Hb Increase ≥1.0 g/dL From Baseline

    Time frame: 26 weeks

    Hb response to FG-4592 is defined as an increase in mean Hb of ≥1.0 g/dL from baseline within any 8-week period during the study without transfusion.

  2. Time to First Hb Response

    Time frame: 26 weeks

    Hb response to FG-4592 is defined as an increase in mean Hb of ≥1.0 g/dL from baseline within any 8-week period during the study without transfusion.

  3. Change From Baseline in Mean Hb in Weeks 25 to 27

    Time frame: Baseline, Weeks 25 to 27

  4. Percentage of Participants With Mean Hb ≥10.0 g/dL Within Any 8-week Period During the Study Without Transfusion

    Time frame: 26 weeks

  5. Number of Participants that Require Transfusions or Hb <6 g/dL up to Week 27

    Time frame: Up to Week 27

  6. Mean Change From Baseline in Functional Assessment of Cancer Therapy - Anemia (FACT-An) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores at Week 27

    Time frame: 30 weeks

    Frame: Baseline, Week 27

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2017
Registry last updated
May 3, 2023

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.