Status:
COMPLETED
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
Lead Sponsor:
FibroGen
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Chronic Kidney Disease
Anemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
Eligibility Criteria
Inclusion
- Age 18 to 75 years
- Chronic kidney disease, not receiving dialysis
- Body weight 45 to 140 kg
Exclusion
- Any clinically significant infection or evidence of an underlying infection
- 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
- New York Heart Association Class III or IV congestive heart failure
- Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
- History of malignancy
- 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 myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
- History of hemosiderosis, hemochromatosis or polycystic kidney disease
- Active hemolysis or diagnosis of hemolytic syndrome
- Uncontrolled or symptomatic secondary hyperparathyroidism
- Seizure disorder or receiving anti-epilepsy medication
- Known bone marrow fibrosis
- Any prior or scheduled organ transplant
- Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
- History of alcohol or drug abuse
Key Trial Info
Start Date :
October 29 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2012
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01244763
Start Date
October 29 2010
End Date
June 13 2012
Last Update
February 10 2022
Active Locations (38)
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1
Mobile, Alabama, United States
2
Pine Bluff, Arkansas, United States
3
Azusa, California, United States
4
Chula Vista, California, United States