NCT03950687

Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis

A Multicenter, Randomized, Open Label, Active Comparator Parallel Controlled Phase 2 Clinical Study on Intravenous Administration of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic renal failure patients with hemodialysis

Detailed description

In this phase 2, open label, active comparator parallel controlled study, patients were randomly assigned to three study groups: one active comparator control group (rHu EPO, maintaining the same dose and frequency administrated in the sceening period ), and two experimental groups (0.5μg/kg ,once a week; 1.0μg/kg , 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

• Chronic Renal Failure With Hemodialysis

Interventions

Type	Name	Description
DRUG	Recombinant Human Erythropoiesis Injection (CHO cell)	rHuEPO 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: 2019-06-24
• Primary completion: 2020-06-30
• Completion: 2020-12-30
• First posted: 2019-05-15
• Last updated: 2020-03-09

Locations

1 site across 1 country: China