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

Anemia in Incident Dialysis Patients Clinical Trial

Official title: Phase 4, Multicenter, Randomized, Open-Lable, Active-Controlled Study of the Efficacy and Safty of HIF-PHI for the Treatment of Anemia and Risks of Cardiovascular and Cerebrovascular Events in Incident-Dialysis Patients

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

There is a screening period of up to 2 weeks, a treatment period of a minimum of 52 weeks and a maximum of approximately up to 3 years after last patient is randomized. A total of up to 400 patients will be randomized in a 1:1 ratio to receive either open-lable HIF-PHI or Active Control (Epoetin alfa). ;

Related Conditions & MeSH terms

• Anemia
• Anemia in Incident Dialysis Patients

• NCT number: NCT04134026
• Study type: Interventional
• Source: Second Xiangya Hospital of Central South University
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 20, 2022
• Completion date: October 19, 2024