Back to resultsCKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CKD-11101
NESP
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria
- Patients with 19 years of age or older
- Patients with anemia in chronic renal failure
Patients who started hemodialysis more than 3 months ago and receive appropriate hemodialysis, satisfying the following criterion:
-Kt/V is ≥ 1.2 or Urea reduction ratio is ≥ 65%
- Patients with the mean Hb levels of 10 to 12g/dl measured at the baseline and randomization visits
Patients with enough body iron stores who meet the following item:
-Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
- Patients who have provided written consent to participate in the trial voluntarily
Exclusion Criteria
- Patients with uncontrolled hypertension
- Patients who had hypersensitivity to erythropoietin agents
- Patients who had known hypersensitivity to mammalian cell-derived products or diluting agents
- Patients with history of severe cardiovascular diseases
- Patients who have received red blood cell transfusion or hormone therapy for anemia correction within 12 weeks prior to randomization
- Patients whose anemia is not caused by chronic renal failure or may affect anemia correction
- Patients whose AST/ALT test results performed at screening exceed twice of normal upper limit
- Patients who had experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
- Patients who have been planned to change the dialysis method
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CKD-11101
NESP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changed amount of mean hemoglobin level in evaluation period compared to the baseline
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
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
Ratio of subjects who achieve target level of hemoglobin during the evaluation period
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
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)
Compare ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period between groups (interval of every 2 weeks)
Ratio of subjects who changed dose during maintenance period and evaluation period
Ratio of subjects who changed dose: Compare ratio of subjects who change dose during maintenance period and evaluation period between groups
Ratio of subjects who receive transfusion during maintenance period and evaluation period
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
Number of red blood cell transfusion per subject during maintenance period and evaluation period
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
Full Information
NCT ID
NCT03428594
First Posted
January 29, 2018
Last Updated
February 5, 2018
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03428594
Brief Title
CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, multi-center, phase 3 clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CKD-11101
Arm Type
Experimental
Arm Description
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.
Arm Title
NESP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CKD-11101
Intervention Type
Biological
Intervention Name(s)
NESP
Primary Outcome Measure Information:
Title
Changed amount of mean hemoglobin level in evaluation period compared to the baseline
Description
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.
Time Frame
([Mean of hemoglobin level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 0])
Title
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24
Description
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.
Time Frame
Weeks 20 - 24
Secondary Outcome Measure Information:
Title
Ratio of subjects who achieve target level of hemoglobin during the evaluation period
Description
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
Time Frame
Weeks 20 - 24
Title
Mean hemoglobin levels at Weeks 20 and 24
Description
Mean hemoglobin level at Weeks 20 and 24: Compare mean hemoglobin level at Weeks 20 and 24 between groups
Time Frame
Weeks 20, 24
Title
Ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period (interval of every 2 weeks)
Description
Compare ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period between groups (interval of every 2 weeks)
Time Frame
Weeks 0 - 24
Title
Ratio of subjects who changed dose during maintenance period and evaluation period
Description
Ratio of subjects who changed dose: Compare ratio of subjects who change dose during maintenance period and evaluation period between groups
Time Frame
Weeks 0 - 24
Title
Ratio of subjects who receive transfusion during maintenance period and evaluation period
Description
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
Time Frame
Weeks 0 - 24
Title
Number of red blood cell transfusion per subject during maintenance period and evaluation period
Description
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
Time Frame
Weeks 0 - 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients with 19 years of age or older
Patients with anemia in chronic renal failure
Patients who started hemodialysis more than 3 months ago and receive appropriate hemodialysis, satisfying the following criterion:
-Kt/V is ≥ 1.2 or Urea reduction ratio is ≥ 65%
Patients with the mean Hb levels of 10 to 12g/dl measured at the baseline and randomization visits
Patients with enough body iron stores who meet the following item:
-Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
Patients who have provided written consent to participate in the trial voluntarily
Exclusion Criteria
Patients with uncontrolled hypertension
Patients who had hypersensitivity to erythropoietin agents
Patients who had known hypersensitivity to mammalian cell-derived products or diluting agents
Patients with history of severe cardiovascular diseases
Patients who have received red blood cell transfusion or hormone therapy for anemia correction within 12 weeks prior to randomization
Patients whose anemia is not caused by chronic renal failure or may affect anemia correction
Patients whose AST/ALT test results performed at screening exceed twice of normal upper limit
Patients who had experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
Patients who have been planned to change the dialysis method
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Kil Park, M.D.,Ph.D.
Organizational Affiliation
Asan Medical Center, College of Medicine, Univ. of Ulsan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis
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