Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Chronic Dialysis Patients
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ClinicalTrials.gov Identifier: NCT04410198 |
Recruitment Status :
Recruiting
First Posted : June 1, 2020
Last Update Posted : July 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia Associated With End Stage Renal Disease (ESRD) | Drug: Roxadustat | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From a Continuous Erythropoietin Receptor Activator (CERA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients |
Actual Study Start Date : | May 27, 2020 |
Estimated Primary Completion Date : | January 1, 2021 |
Estimated Study Completion Date : | July 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Roxadustat |
Drug: Roxadustat
This open-label single arm study is designed to evaluate roxadustat dosing in maintaining hemoglobin in ESRD subjects receiving chronic dialysis treatments |
- Proportion of subjects with mean Hb >= 10g/dL [ Time Frame: Week 16-24 ]
- Mean hemoglobin change from baseline to average Hb from week 16-24 [ Time Frame: Week 16-24 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Receiving chronic dialysis for end stage renal disease (ESRD)
- Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunneled catheter
- Screening hemoglobin criteria: Subjects converting from an ESA: between 9.0 to 12.0 g/dL; Subjects initiating anemia treatment: < 10.0 g/dL
- Ferritin ≥ 50 ng/mL, Transferrin saturation (TSAT) ≥ 10% at screening
- Subject's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤ 1.5 x ULN at screening and prior to initiating roxadustat treatment.
- Body weight between 45.0 to 160.0 kg
Key Exclusion Criteria:
- Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
- Known history of myelodysplastic syndrome or multiple myeloma
- Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
- Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
- Active or chronic gastrointestinal bleeding
- Treated with iron-chelating agents within 4 weeks prior to enrollment
- History of New York Heart Association (NYHA) Class III or IV congestive heart failure
- History of MI, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
- Uncontrolled hypertension, in the opinion of the Investigator
- Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment
- History of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps

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): NCT04410198
Contact: Gopal Saha, MBBS | 415.978.1661 | gsaha@fibrogen.com |
United States, Colorado | |
Investigational Site | Recruiting |
Englewood, Colorado, United States, 80110 | |
Contact: Joanne Stevens | |
United States, Idaho | |
Investigational Site | Recruiting |
Caldwell, Idaho, United States, 83642 | |
Contact: Joanne Stevens | |
United States, Louisiana | |
Investigational Site | Recruiting |
Baton Rouge, Louisiana, United States, 70808 | |
Contact: Jane Byrne | |
United States, Michigan | |
Investigational Site | Recruiting |
Kalamazoo, Michigan, United States, 49009 | |
Contact: Brianna Atkinson | |
United States, Mississippi | |
Investigational Site | Recruiting |
Tupelo, Mississippi, United States, 38801 | |
Contact: Alicia Butram | |
United States, Missouri | |
Investigational Site | Recruiting |
Saint Ann, Missouri, United States, 63074 | |
Contact: Pamela Pettiford | |
United States, Nevada | |
Investigational Site | Recruiting |
Las Vegas, Nevada, United States, 89106 | |
Contact: Lloyd Fajardo | |
United States, Texas | |
Investigational Site | Recruiting |
Sugar Land, Texas, United States, 77479 | |
Contact: Joanne Stevens | |
United States, Utah | |
Investigational Site | Recruiting |
Saint George, Utah, United States, 84790 | |
Contact: Laura Shafer |
Study Chair: | Peony Yu | FibroGen |
Responsible Party: | FibroGen |
ClinicalTrials.gov Identifier: | NCT04410198 |
Other Study ID Numbers: |
FGCL-4592-097 |
First Posted: | June 1, 2020 Key Record Dates |
Last Update Posted: | July 23, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Failure, Chronic Anemia Hematologic Diseases Kidney Diseases |
Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |