AzTrials
AzTrials

AnemiaPhase 2/3NCT03303066

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

A Phase 2/3 study testing FG-4592 in people with Anemia and Myelodysplastic Syndrome, run by Kyntra Bio at 38 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anemia, Myelodysplastic Syndrome
What is being tested?
FG-4592
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
38 sitesChina
Study dates
6 Jun 2018to 8 Feb 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

China38 sites

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Xiyuan Hospital, CACMS

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Guangdong General Hospital

    Guangzhou, Guangdong

  • Nan Fang Hospital

    Guangzhou, Guangdong

  • Hainan Central Hospital

    Haikou, Hainan

  • The First Affiliated Hospital, Zhejiang University Medical College

    Hangzhou, Zhejiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • The Affiliated Hospital of Xuzhou Medical University

    Jinan, Shandong

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality

  • Second hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The First Affiliated Hospital Of Soochow University

    Suzhou, Jiangsu

  • Blood disease hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei

  • Union Hospital Affiliated Tongji Medical College Huazhong University of Science and Technolog

    Wuhan, Hubei

  • Shaanxi Provincial People's Hospital

    Xian, Shanxi

  • The First Affiliated Hospital of Xi'an Jiao Tong University Medical College

    Xian, Shanxi

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • Tumor Hospital of Henan province

    Zhengzhou, Henan

  • Zhuzhou Central Hospital

    Zhuzhou, Guangdong

Other trials in China

About this study

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

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.

Being tested
FG-4592, Placebo
Keywords
Myelodysplastic Syndromes, Anemia, Hemoglobin (Hb), Low Risk Myelodysplastic Syndrome
Medical subject headings
Anemia, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FG-4592Drug

    Also called Roxadustat, AZD9941

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT03303066
Study groupRoleWhat they receive
Phase 2 Part: FG-4592ExperimentalFixed 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.
Receives: Drug: FG-4592
Phase 3 Part: FG-4592ExperimentalFixed 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.
Receives: Drug: FG-4592
Phase 3 Part: PlaceboPlacebo comparatorPlacebo (matching to FG-4592) administered orally TIW for up to 26 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 26 weeks

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 26 weeks

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

    Measured: 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

    Measured: 26 weeks

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

    Measured: 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

    Measured: 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2017
  2. Study start6 Jun 2018
  3. Primary completion11 Jan 2023
  4. Study completion8 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03303066
Sponsor's protocol ID
FGCL-4592-813
Status last verified
Apr 2023
First submitted
2 Oct 2017
Last updated
3 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing FG-4592 in people with Anemia and Myelodysplastic Syndrome, run by Kyntra Bio at 38 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Hemoglobin (Hb) Response to FG-4592 Without Transfusion (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03303066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in