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Clinical Trial Summary

To verify the efficacy of recombinant erythropoiesis stimulating protein injection (CHO cell) in hemodialysis patients with chronic renal failure anemia maintenance treatment is not inferior to yibio.

Clinical Trial Description

In this phase 3, open label, active comparator parallel controlled study, patients were randomly assigned to two study groups: one active comparator control group (Human Erythropoietin Injection , maintaining the same dose and frequency administrated in the sceening period ), and experimental groups (50μg, once every two weeks). All the patients were administered intravenously for 32 weeks and were evaluated the efficacy, safety and pharmacokinetic characteristics. During the whole study period, dosage adjustment was not allowed in the first 4 weeks, while in the remaining trial period dosage adjustment was allowed once every two weeks if necessary. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05211167
Study type Interventional
Source Shenyang Sunshine Pharmaceutical Co., LTD.
Contact Gang Tong, MD
Phone 021-60970099
Status Recruiting
Phase Phase 3
Start date July 1, 2021
Completion date December 30, 2023

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