NCT04134026

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

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: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Anemia in Incident Dialysis Patients

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-10-19
• Completion: 2024-10-19
• First posted: 2019-10-21
• Last updated: 2021-05-25

Locations

1 site across 1 country: China