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Chemotherapy Induced AnemiaPhase 3NCT05301517

A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

A Phase 3 study testing SEPO® and Roxadustat in people with Chemotherapy Induced Anemia, run by Kyntra Bio at 45 sites in China.

Completed

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

Official record
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Trial summary

The main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy Induced Anemia
What is being tested?
SEPO® and Roxadustat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
45 sitesChina
Study dates
16 Mar 2022to 21 Apr 2023
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of non-myeloid malignancy, by histological or cytological confirmation.
  • Anemia related to myelosuppressive chemotherapy, defined as Hb ≤100 g/L at screening with documented participant's Hb level decrease ≥10 g/L after the initiation of chemotherapy as judged by the investigator.
  • Planned concurrent treatment of cancer (myelosuppressive chemotherapy) for at least 8 additional weeks.
  • Body weight ≥40 kg.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2.
  • Ferritin ≥50 nanograms (ng)/milliliter (mL) and transferrin saturation (TSAT) ≥10%.

Who cannot join

  • Participants with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Participants who are only receiving hormonal products, biological products, novel immunosuppressive products (such as programmed cell death protein-1 [PD-1] and programmed death-ligand 1 [PD-L1] checkpoint inhibitors) or targeted biological or radiation therapy to treat/manage their cancer, however if chemotherapy is co-administered with these products, then it is acceptable to enroll the participant.
  • Participants with hematocrit (HCT) ≥36%.
  • Participants who have received an RBC transfusion or ESA within 4 weeks of randomization.
  • Thromboembolic event (including but not limited to deep vein thrombosis [DVT], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack [TIA] within previous 6 months of screening.
  • Clinically significant anemia due to other etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or hereditary anemia such as sickle cell anemia or thalassemia.
  • The Investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical conditions.
  • Note: Other inclusion and exclusion criteria may apply.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

China45 sites

  • Affiliated Hospital of Hebei University

    Baoding

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing

  • Capital Medical University Chest Hospital

    Beijing

  • Peking University Cancer Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Sichuan Cancer Hospital

    Chengdu

  • Chongqing Bishan People's Hospital

    Chongqing

  • The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)

    Chongqing

  • Deyang People's Hospital

    Deyang

  • The First People's Hospital of Foshan

    Foshan

  • Fujian Medical University Union Hospital

    Fuzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Gynecologic Oncology Department

    Guangzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Oncology Department

    Guangzhou

  • Hangzhou Cancer Hospital

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Anhui Cancer Hospital

    Hefei

  • Jiangxi Cancer Hospital

    Jiangxi

  • Shandong First Medical University Cancer Hospital

    Jinan

  • The Second Hospital of Lanzhou University

    Lanzhou

  • Jiangsu Province Hospital

    Nanjing

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning

  • Neijiang Second People's Hospital

    Neijiang

  • Ningbo First Hospital

    Ningbo

  • Jiangxi Pingxiang People's Hospital

    Pingxiang

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Shanghai Chest Hospital

    Shanghai

  • Shanghai Fifth People's Hospital

    Shanghai

  • Liaoning Cancer Hospital & Institute

    Shenyang

  • The First Hospital of China Medical University - Oncology Department Breast Cancer Group

    Shenyang

  • The First Hospital of China Medical University - Oncology Department Lung Cancer Group

    Shenyang

  • Peking University Shenzhen Hospital

    Shenzhen

  • Shanxi Cancer Hospital

    Taiyuan

  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • University of Science and Technology

    Wuhan

  • Wuhan Fourth Hospital

    Wuhan

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Cancer Hospital of Xinjiang Medical University

    Xinjiang

  • Xuzhou Central Hospital

    Xuzhou

  • Yantai Yuhuangding Hospital

    Yantai

  • General Hospital of Ningxia Medical University

    Yinchuan

  • Henan Cancer Hospital

    Zhengzhou

  • Zhuzhou Central Hospital

    Zhuzhou

Other trials in China

About this study

Official title: A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

The main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.

Read the detailed description

Participants who are eligible for participation will be randomized to roxadustat and SEPO® (recombinant human erythropoietin-α [rHuEPO-α]), and undergo a 12-week treatment period followed by a 4-week follow-up period.

Being tested
SEPO®, Roxadustat

What participants receive

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

  • SEPO®Drug

    Also called Recombinant human erythropoietin-α [rHuEPO-α]

    SEPO® will be administered per dose and schedule specified in the arm description.

  • RoxadustatDrug

    Also called FG-4592

    Roxadustat will be administered per dose and schedule specified in the arm description.

Study groups in NCT05301517
Study groupRoleWhat they receive
RoxadustatExperimentalParticipants will receive roxadustat, administered orally 3 times per week (TIW) for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be based on the participant's weight group. The maximum dose for individual participants may not exceed 3.5 milligrams (mg)/kilogram (kg) or 400 mg TIW whichever is lower.
Receives: Drug: Roxadustat
SEPO®Active comparatorParticipants will receive SEPO®, injected subcutaneously TIW for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be 150 international units (IU)/kg subcutaneously TIW.
Receives: Drug: SEPO®

What is being measured

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

  1. Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13

    Hb levels measured from Weeks 9 through 13 will be averaged in order to provide a single measure for comparison to the baseline Hb levels.

    Measured: Baseline, Weeks 9 through 13

Secondary outcomes (15)

  1. Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13

    Measured: Baseline through Week 13

  2. Percentage of Participants who Require Red Blood Cell (RBC) Transfusion or Hb <60 g/L or with any Hb< 60 g/L From Week 5 Through Week 13

    Measured: Week 5 through Week 13

  3. Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale Score Averaged Over Weeks 9-13

    FACT-An subscale scores will be averaged over Weeks 9 through 13 in order to provide a single measure for comparison to the baseline score.

    Measured: Baseline, Weeks 9 through 13

  4. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Subscale Score Averaged Over Weeks 9-13

    FACIT-F subscale scores will be averaged over Weeks 9 through 13 in order to provide a single measure for comparison to the baseline score.

    Measured: Baseline, Weeks 9 through 13

  5. Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia

    Measured: Baseline through Week 13

  6. Change in Hb From Baseline up to 4 Weeks After the Last Dose of Chemotherapy During the Treatment Period

    Measured: Baseline up to 4 weeks after the last dose of chemotherapy (up to Week 16)

  7. Change in Hb From Baseline Through Week 9

    Measured: Baseline through Week 9

  8. Change in Hb From Baseline Through Week 13

    Measured: Baseline through Week 13

  9. Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13

    Measured: Baseline through Week 13

  10. Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From Baseline Through Week 13

    Measured: Baseline through Week 13

  11. Percentage of Participants who Achieve an Increase in Hb of 15 g/L or Attaining a Hb of 110 g/L From Baseline Through Week 13

    Measured: Baseline through Week 13

  12. Time to First RBC Transfusion

    Measured: Baseline up to Week 13

  13. Percentage of Participants Requiring 1 or More RBC Transfusion

    Measured: Baseline up to Week 13

  14. Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13

    Measured: Baseline through Week 13

  15. Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent

    Measured: Baseline through Week 13

Timeline

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

  1. First posted29 Mar 2022
  2. Study start16 Mar 2022
  3. Primary completion3 Apr 2023
  4. Study completion21 Apr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05301517
Sponsor's protocol ID
FGCL-4592-898
Status last verified
Jun 2023
First submitted
19 Mar 2022
Last updated
6 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu S, Wu J, Jiang J, Guo Q, Yu Y, Liu Y, Zhang H, Qian L, Dai X, Xie Y, Fu T, Lee T, Lu Y, Ma R, Eisner MD. Efficacy and Safety of Roxadustat for Anemia in Patients Receiving Chemotherapy for Nonmyeloid Malignancies: A Randomized, Open-Label, Active-Controlled Phase III Study. J Clin Oncol. 2025 Jan 10;43(2):143-153. doi: 10.1200/JCO.23.02742. Epub 2024 Oct 1.

    PubMed 39353163

  • Glaspy J, Gabrail NY, Locantore-Ford P, Lee T, Modelska K, Samal V, Henry DH. Open-label, Phase 2 study of roxadustat for the treatment of anemia in patients receiving chemotherapy for non-myeloid malignancies. Am J Hematol. 2023 May;98(5):703-711. doi: 10.1002/ajh.26865. Epub 2023 Feb 24.

    PubMed 36710399

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SEPO® and Roxadustat in people with Chemotherapy Induced Anemia, run by Kyntra Bio at 45 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 6 inclusion and 8 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13 (time frame: Baseline, Weeks 9 through 13). 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 NCT05301517, which also lists 2 linked publications.

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 6 Jun 2023.

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