Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Roxadustat Conversion in Subjects Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis 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: NCT04484857
Recruitment Status : Active, not recruiting
First Posted : July 24, 2020
Last Update Posted : April 22, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
FibroGen

Brief Summary:
The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among hemodialysis subjects converted from ESA therapy or who are ESA-naïve.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 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 an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
Actual Study Start Date : July 17, 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

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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): NCT04484857


Locations
Show Show 26 study locations
Sponsors and Collaborators
FibroGen
AstraZeneca
Investigators
Layout table for investigator information
Study Chair: Mark Eisner FibroGen
Layout table for additonal information
Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT04484857    
Other Study ID Numbers: FGCL-4592-096
First Posted: July 24, 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

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