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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410198
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : April 22, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
FibroGen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anemia Associated With End Stage Renal Disease (ESRD) Drug: Roxadustat Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 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 : July 31, 2021
Estimated Study Completion Date : August 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with mean Hb >= 10g/dL [ Time Frame: Week 16-24 ]
  2. Mean hemoglobin change from baseline to average Hb from week 16-24 [ Time Frame: Week 16-24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Colorado
Investigational Site
Englewood, Colorado, United States, 80110
United States, Idaho
Investigational Site
Caldwell, Idaho, United States, 83642
United States, Louisiana
Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
Investigational Site
Kalamazoo, Michigan, United States, 49009
United States, Mississippi
Investigational Site
Tupelo, Mississippi, United States, 38801
United States, Missouri
Investigational Site
Saint Ann, Missouri, United States, 63074
United States, Nevada
Investigational Site
Las Vegas, Nevada, United States, 89106
United States, Texas
Investigational Site
Sugar Land, Texas, United States, 77479
United States, Utah
Investigational Site
Saint George, Utah, United States, 84790
Sponsors and Collaborators
FibroGen
AstraZeneca
Investigators
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Study Chair: Mark Eisner FibroGen
More Information
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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: April 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Anemia
Hematologic Diseases
Kidney Diseases
 Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency