Status:
UNKNOWN
Roxadustat for Anemia in Patients With CKD
Lead Sponsor:
Shenzhen Second People's Hospital
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Brief Summary
A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is ...
Detailed Description
The prevalence of anemia in patients with chronic kidney disease (CKD) (15.4%) is twice that of the general population (7.6%), and the degree of anemia increases with the severity of CKD. A number of ...
Eligibility Criteria
Inclusion
- the patient did not receive ESA treatment.The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) was \<10 g/dL.
- Or patients who have received ESA:
- Patients with renal anemia who received ESA for at least 4 weeks within the approved dose range in China before the screening evaluation.
- The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) \>=7 g/dL and \<=12.0 g/dL;
- The expected survival time is more than 1 year;
Exclusion
- a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis;
- preparing for pregnancy or pregnancy or lactation;
- having anemia caused by any other disease other than CKD, such as thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, tumor-related anemia, chemotherapy-related anemia, and myelodysplastic syndrome;
- malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed
- .Any red blood cell infusion during the screening period;
- The patient is known to be allergic to the active substance (Roxadustat) or any excipient of the product;
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04502537
Start Date
February 1 2021
End Date
September 30 2023
Last Update
January 22 2021
Active Locations (1)
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1
Shenzhen Second People's Hospital
Shenzhen, China