Status:
COMPLETED
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
Lead Sponsor:
FibroGen
Conditions:
CKD Anemia in Dialysis Participants
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over ...
Detailed Description
Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one o...
Eligibility Criteria
Inclusion
- 1\. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)
Exclusion
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
- Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.
- History of malignancy, myelodysplastic syndrome, and multiple myeloma.
- Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis \[SLE\], rheumatoid arthritis, celiac disease).
- Clinically significant gastrointestinal bleeding.
- Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT04059913
Start Date
June 11 2019
End Date
December 17 2021
Last Update
May 6 2022
Active Locations (25)
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1
Investigational Site
Hefei, Anhui, China, 230601
2
Investigational Site
Lanzhou, Gansu, China, 730030
3
Investigational Site
Guangzhou, Guangdong, China, 510515
4
Investigational Site
Shenzhen, Guangdong, China, 518020