NCT03428594

CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluation the Efficacy and Safety of Intravenous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Receiving Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare and evaluate efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis.

Detailed description

This study was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who had renal anemia receiving hemodialysis. The selection criteria are evaluated for 19-year-old patients who receive stable hemodialysis treatment for 3 months or more in patients with chronic renal failure. After completion of the stabilization period of 12 to 16 weeks for Darbepoetin Alfa, the subjects with the mean Hb levels of 10 to 12g/dl measured during the baseline visit and 0 week visit are randomized to the test and control groups in a 1:1 ratio during the randomization visit. They have a 20-week maintenance period and a 4-week evaluation period.

Conditions

• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	CKD-11101
BIOLOGICAL	NESP

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2018-02-09
• Last updated: 2018-02-09