NCT03431623

CKD-11101 Phase 3 SC Study

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Subcutaneous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Not on Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (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 subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.

Detailed description

This was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin Alfa in patients who had stage 3, stage 4, and stage 5 chronic renal failure not on hemodialysis or peritoneal dialysis. The selection criteria will be evaluated in patients who are receiving anemia correction among patients with 19 years of age or older and who had anemia in chronic renal failure of stage 3 or above. Subjects who are identified to meet all inclusion criteria will be randomized to test group and control group at 1:1 ratio and go through 24-week correction period and efficacy evaluation period. During correction period and efficacy evaluation period, subjects will visit the clinical study center every 2 weeks to receive processes designated for each visit and be administered investigational product from the investigator in charge of drug administration. In the safety evaluation period, all subjects will be administered test drug for 28weeks.

Conditions

• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	CKD-11101(Darbepoetin alfa)
BIOLOGICAL	NESP(Darbepoetin alfa)

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-02-01
• Completion: 2017-08-01
• First posted: 2018-02-13
• Last updated: 2018-02-13