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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Sponsor:
FibroGen
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
FibroGen
Tracking Information | |||||
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First Submitted Date ICMJE | May 27, 2020 | ||||
First Posted Date ICMJE | June 1, 2020 | ||||
Last Update Posted Date | July 23, 2020 | ||||
Actual Study Start Date ICMJE | May 27, 2020 | ||||
Estimated Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Chronic Dialysis Patients | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis subjects converted from ESA therapy or who are ESA-naïve. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Anemia Associated With End Stage Renal Disease (ESRD) | ||||
Intervention ICMJE | Drug: Roxadustat
This open-label single arm study is designed to evaluate roxadustat dosing in maintaining hemoglobin in ESRD subjects receiving chronic dialysis treatments
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Study Arms ICMJE | Experimental: Roxadustat
Intervention: Drug: Roxadustat
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
200 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 1, 2021 | ||||
Estimated Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04410198 | ||||
Other Study ID Numbers ICMJE | FGCL-4592-097 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | FibroGen | ||||
Study Sponsor ICMJE | FibroGen | ||||
Collaborators ICMJE | AstraZeneca | ||||
Investigators ICMJE |
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PRS Account | FibroGen | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |