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CompletedNCT03303066Updated May 3, 2023

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

A Phase 2/3 interventional study of FG-4592 and Placebo in Anemia and Myelodysplastic Syndrome, sponsored by FibroGen. Completed at 38 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by FibroGen · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Anemia
  • Myelodysplastic Syndrome

Keywords

  • Myelodysplastic Syndromes
  • Anemia
  • Hemoglobin (Hb)
  • Low Risk Myelodysplastic Syndrome
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Phase 2 Part: FG-4592

    Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally 3 times a week (TIW) for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.

    Drug: FG-4592

  • Experimental
    Phase 3 Part: FG-4592

    Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally TIW for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.

    Drug: FG-4592

  • Placebo comparator
    Phase 3 Part: Placebo

    Placebo (matching to FG-4592) administered orally TIW for up to 26 weeks.

    Drug: Placebo

Interventions

  • DrugFG-4592

    Oral

    Also known as: Roxadustat, AZD9941

  • DrugPlacebo

    Oral

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: 26 weeks

Secondary outcomes

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

    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.

    Time frame: 26 weeks

  2. Time to First Hb Response

    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.

    Time frame: 26 weeks

  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

    Frame: Baseline, Week 27

    Time frame: 30 weeks

06

Study locations

38 sites
  • The First Affiliated Hospital of Bengbu Medical College
    Bengbu, Anhui, China
  • Anhui Provincial Hospital
    Hefei, Anhui, China
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui, China
  • China-Japan Friendship Hospital
    Beijing, Beijing, China
  • Peking Union Medical College Hospital
    Beijing, Beijing, China
  • Peking University First Hospital
    Beijing, Beijing, China
  • Peking University Third Hospital
    Beijing, Beijing, China
  • Xiyuan Hospital, CACMS
    Beijing, Beijing, China
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian, China
  • Lanzhou University Second Hospital
    Lanzhou, Gansu, China
  • Guangdong General Hospital
    Guangzhou, Guangdong, China
  • Nan Fang Hospital
    Guangzhou, Guangdong, China
  • Zhuzhou Central Hospital
    Zhuzhou, Guangdong, China
  • Hainan Central Hospital
    Haikou, Hainan, China
  • Second hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
  • Tumor Hospital of Henan province
    Zhengzhou, Henan, China
  • Tongji Hospital, Tongji Medical College of HUST
    Wuhan, Hubei, China
  • Union Hospital Affiliated Tongji Medical College Huazhong University of Science and Technolog
    Wuhan, Hubei, China
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan, China
  • Jiangsu Province Hospital
    Nanjing, Jiangsu, China
  • Zhongda Hospital Southeast University
    Nanjing, Jiangsu, China
  • The First Affiliated Hospital Of Soochow University
    Suzhou, Jiangsu, China
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu, China
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    Jinan, Shandong, China
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
  • The Affiliated Hospital of Xuzhou Medical University
    Jinan, Shandong, China
  • Huashan Hospital Affiliated to Fudan University
    Shanghai, Shanghai, China
  • Shanghai Sixth People's Hospital
    Shanghai, Shanghai, China
  • Shanghai Tongji Hospital
    Shanghai, Shanghai, China
  • Shaanxi Provincial People's Hospital
    Xian, Shanxi, China
  • The First Affiliated Hospital of Xi'an Jiao Tong University Medical College
    Xian, Shanxi, China
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan, China
  • West China Hospital, Sichuan University
    Chengdu, Sichuan, China
  • Blood disease hospital of Chinese Academy of Medical Sciences
    Tianjin, Tianjin, China
  • The Second Hospital of Tianjin Medical University
    Tianjin, Tianjin, China
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin, China
  • First Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan, China
  • The First Affiliated Hospital, Zhejiang University Medical College
    Hangzhou, Zhejiang, China
07

Registry details

Key details

Study ID
NCT03303066
Lead sponsor
FibroGen
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Oct 5, 2017
Start date
Jun 6, 2018
Primary completion
Jan 11, 2023
Completion
Feb 8, 2023
Last update
May 3, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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