Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure

Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure

Brief 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.

Detailed 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 Type: Interventional (Clinical Trial)
Estimated Enrollment: 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Parallel-controlled Phase III Trial Comparing the Efficacy and Safety of Recombinant Erythropoiesis Stimulating Protein Injection (CHO Cell) With Ipbio in Maintenance Therapy in Hemodialysis Patients With Anemia in Chronic Renal Failure
Actual Study Start Date: July 1, 2021
Estimated Primary Completion Date: June 30, 2023
Estimated Study Completion Date: December 30, 2023

Arm:
- Active Comparator: Group A
- Experimental: Group B

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