NCT05211167

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure, Chronic
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Human Erythropoiesis Injection (CHO cell)	Human Erythropoiesis Injection (CHO cell) is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
DRUG	Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)	rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2022-01-27
• Last updated: 2022-01-27

Locations

1 site across 1 country: China