NCT05629598

A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .

A Phase Ⅱ Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Polyethylene Glycol Recombinant Human Erythropoietin Injection (CHO Cell) in Optimal Dose and Administration Regimen for Maintenance Therapy in Patients With Regular Dialysis Renal Anemia.

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

Summary

The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.

Detailed description

This study is a multi-center, randomized, open-label, positive controlled phase II clinical study. A total of 125 to 150 patients with renal anemia receiving regular dialysis were enrolled in this study. Those patients were randomly allocated to 5 treatment groups in a ratio of 1:1:1:1:1, with 25 to 30 patients in each group.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant human erythropoietin injection	The dose of PEG-EPO (CHO cells) is converted according to the average weekly dose of short-acting EPO before randomization (4 weeks before randomization) multiplied by the corresponding conversion coefficient (low conversion coefficient is 0.004, High conversion coefficient is 0.008).
BIOLOGICAL	Human erythropoietin injection	Refer to the product instructions

Timeline

• Start date: 2022-04-13
• Primary completion: 2023-03-17
• Completion: 2023-08-16
• First posted: 2022-11-29
• Last updated: 2022-11-29

Locations

1 site across 1 country: China