Evaluate the Efficacy and Safety of HIF-PHI for the Treatment of Anemia and Risks of Cardiovascular and Cerebrovascular Events in ESRD Newly Initiated Dialysis Patients
NCT04134026 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2021-05-25
Summary
The purpose of the study is to determin whether HIF-PHI is safe and effective in the treatment of anemia and meanwhile reduces the risk of cardiovascular and cerebrovascular events in patients who have just initiated dialysis.
Conditions
- Anemia in Incident Dialysis Patients
Interventions
- DRUG
-
HIF-PHI
Drug will be dosed orally three times a week.
- DRUG
-
Epoetin Alfa
The drug will be dispensed per the package insert or the country-specific product labeling.
Sponsors & Collaborators
-
Second Xiangya Hospital of Central South University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-20
- Primary Completion
- 2023-10-19
- Completion
- 2024-10-19
Countries
- China
Study Locations
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