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

Phase 3

Completed

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Biological: NESP; Biological: CKD-11101

• Registration Number: NCT03428594
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Study First Submitted: 2018-01-29
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NESP	NESP	The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.
CKD-11101	CKD-11101	The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.

Primary Outcome Measures

Name	Time	Method
Changed amount of mean hemoglobin level in evaluation period compared to the baseline	([Mean of hemoglobin level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 0])	The equivalence test on mean hemoglobin level of test drug and to Reference Drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Weeks -4 - 0) will be conducted.
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24	Weeks 20 - 24	The equivalence test on mean administration dose of test drug and to Reference Drug administration groups in evaluation period (Weeks 20 - 24) will be conducted.

Secondary Outcome Measures

Name	Time	Method
Ratio of subjects who receive transfusion during maintenance period and evaluation period	Weeks 0 - 24	Ratio of subjects who receive red blood cell transfusion: Compare ratio of subjects who receive red blood cell transfusion during maintenance period and evaluation period between groups
Ratio of subjects who changed dose during maintenance period and evaluation period	Weeks 0 - 24	Ratio of subjects who changed dose: Compare ratio of subjects who change dose during maintenance period and evaluation period between groups
Number of red blood cell transfusion per subject during maintenance period and evaluation period	Weeks 0 - 24	Number of red blood cell transfusion per subject: Compare number of red blood cell transfusion per subject during maintenance period and evaluation period between groups
Ratio of subjects who achieve target level of hemoglobin during the evaluation period	Weeks 20 - 24	Ratio of subjects who maintain target level of hemoglobin: Compare the number of subjects who do not deviate from target level of hemoglobin during the evaluation period between groups
Mean hemoglobin levels at Weeks 20 and 24	Weeks 20, 24	Mean hemoglobin level at Weeks 20 and 24: Compare mean hemoglobin level at Weeks 20 and 24 between groups
Ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period (interval of every 2 weeks)	Weeks 0 - 24	Compare ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period between groups (interval of every 2 weeks)