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

Phase 3 Unknown 300 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2021-07-01
Primary completion: 2023-06-30
Completion: 2023-12-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	epoetin alfa	Protein / enzyme biologic	—	Intravenous
Subject	rESP	Unknown	50 ug	Intravenous

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

Summary

Timeline

Drugs

Indications