Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
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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: NCT04076943 |
Recruitment Status :
Recruiting
First Posted : September 4, 2019
Last Update Posted : September 3, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy Induced Anemia | Drug: Roxadustat (FG-4592) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Open Label Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients Receiving Chemotherapy Treatment for Non-Myeloid Malignancies |
Actual Study Start Date : | August 6, 2019 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | May 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Roxadustat (FG-4592) |
Drug: Roxadustat (FG-4592)
Roxadustat will be dosed orally three times a week. |
- Maximum change in Hemoglobin within 16 weeks [ Time Frame: Baseline to Week 16 ]The primary efficacy endpoint is maximum change in hemoglobin within 16 weeks from baseline without RBC transfusion
- Mean change in hemoglobin level [ Time Frame: Baseline to Week 16 ]Mean change in hemoglobin level from baseline to week 16 (without RBC transfusion)
- Change in hemoglobin [ Time Frame: Baseline to Week 16 ]Change in hemoglobin from baseline at Week 8, 12, 16 (without RBC transfusion)
- RBC transfusion [ Time Frame: Week 5 to Week 16 ]Number (%) of patients who had a RBC transfusion from beginning of Week 5 (Day 29)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of non-myeloid malignancy
- Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 g/dL at screening
- Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks
- Estimated life expectancy ≥ 6 months at enrollment (Day 1)
Exclusion Criteria:
- Patients with cancer receiving chemotherapy when the anticipated outcome is cure
- Patients who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy
- History of leukemia
- Patients who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
- Any investigational drug within 8-weeks prior to treatment with roxadustat
- Anemia due to other etiologies
- Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening
- Clinically significant or uncontrolled ongoing autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
- Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection

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): NCT04076943
Contact: Gopal Saha | (415) 978-1661 | gsaha@Fibrogen.com | |
Contact: Charles Bradley | (415) 978-1672 | cbradley@Fibrogen.com |
United States, California | |
Research Center | Recruiting |
Los Alamitos, California, United States, 90720 | |
Research Center | Recruiting |
Los Angeles, California, United States, 90024 | |
Research Center | Recruiting |
Torrance, California, United States, 90505 | |
United States, Florida | |
Research Center | Recruiting |
Jacksonville, Florida, United States, 32256 | |
Research Center | Recruiting |
Plantation, Florida, United States, 33322 | |
United States, Indiana | |
Research Center | Recruiting |
Fort Wayne, Indiana, United States, 46804 | |
United States, Kentucky | |
Research Center | Recruiting |
Ashland, Kentucky, United States, 41101 | |
United States, Louisiana | |
Research Center | Recruiting |
Covington, Louisiana, United States, 70433 | |
United States, Maryland | |
Research Center | Recruiting |
Bethesda, Maryland, United States, 20817 | |
United States, New Jersey | |
Research Center | Recruiting |
Livingston, New Jersey, United States, 07039 | |
United States, New York | |
Research Center | Recruiting |
Bronx, New York, United States, 10469 | |
Research Center | Recruiting |
Port Jefferson Station, New York, United States, 11776 | |
United States, Ohio | |
Research Center | Recruiting |
Canton, Ohio, United States, 44718 | |
United States, Pennsylvania | |
Research Center | Recruiting |
Gettysburg, Pennsylvania, United States, 17325 | |
Research Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19106 |
Responsible Party: | FibroGen |
ClinicalTrials.gov Identifier: | NCT04076943 |
Other Study ID Numbers: |
FGCL-4592-092 |
First Posted: | September 4, 2019 Key Record Dates |
Last Update Posted: | September 3, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Anemia Chemotherapy induced anemia Myelosuppressive chemotherapy Non-Myeloid malignances |
Anemia Hematologic Diseases |