drugset / Trial / NCT03950687

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

NCT03950687

Phase 2 Unknown 150 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2019-06-24
Primary completion
2020-06-30
Completion
2020-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator epoetin alfa Protein / enzyme biologic Intravenous
Subject rESP Protein / enzyme biologic 0.5 ug/kg Intravenous
Subject rESP Protein / enzyme biologic 1 ug/kg Intravenous