Status:
COMPLETED
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
Lead Sponsor:
FibroGen
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Dialysis
Anemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
Detailed Description
Participants on hemodialysis (HD) will be randomized to 3 treatment arms (A, B, and C) of in a 1:1:1 ratio to receive no iron supplementation, oral iron supplementation, and IV iron supplementation, r...
Eligibility Criteria
Inclusion
- Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization
- Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be \<10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values
- Body weight 40 to 140 kilograms (kg)
Exclusion
- Previously received erythropoiesis-stimulating agents
- Received IV iron within 4 weeks of randomization
- Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
- Clinically significant infection
- New York Heart Association Class III or IV congestive heart failure
- History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
- Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- History of other blood disorders
- Active hemolysis or diagnosis of hemolytic syndrome
- Known bone marrow fibrosis
- Uncontrolled or symptomatic secondary hyperparathyroidism
- History of alcohol or drug abuse within a year prior to randomization, or anticipated inability to avoid consumption of more than 3 alcoholic beverages per day
- History of allergy or sensitivity to oral or IV iron therapy
- Seizure disorder or receiving anti-epilepsy medication for seizure disorder within 12 weeks prior to randomization
- Pregnant or breast-feeding females
Key Trial Info
Start Date :
July 21 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01414075
Start Date
July 21 2011
End Date
January 10 2013
Last Update
October 1 2021
Active Locations (7)
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1
Northridge, California, United States
2
Yuba City, California, United States
3
Detroit, Michigan, United States
4
Hong Kong, Hong Kong