Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Chronic Dialysis Patients

• ClinicalTrials.gov Identifier: NCT04410198
• Recruitment Status: Recruiting
• First Posted: June 1, 2020
• Last Update Posted: July 23, 2020
• Sponsor: FibroGen
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): FibroGen

Tracking Information

• First Submitted Date: May 27, 2020
• First Posted Date: June 1, 2020
• Last Update Posted Date: July 23, 2020
• Actual Study Start Date: May 27, 2020
• Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2020)

• 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Chronic Dialysis Patients
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Anemia Associated With End Stage Renal Disease (ESRD)

Intervention

Drug: Roxadustat

This open-label single arm study is designed to evaluate roxadustat dosing in maintaining hemoglobin in ESRD subjects receiving chronic dialysis treatments

Study Arms

Experimental: Roxadustat

Intervention: Drug: Roxadustat

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 27, 2020): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2021
• Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Gopal Saha, MBBS; 415.978.1661; gsaha@fibrogen.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04410198
• Other Study ID Numbers: FGCL-4592-097
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: FibroGen
• Study Sponsor: FibroGen
• Collaborators: AstraZeneca

Investigators

• Study Chair: Peony Yu; FibroGen

• PRS Account: FibroGen
• Verification Date: July 2020