Back to resultsCKD-11101 Phase 3 SC Study
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CKD-11101(Darbepoetin alfa)
NESP(Darbepoetin alfa)
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 chronic renal failure of stage 3 or above who are not on dialysis
- Patients with the Hb levels of 8 to 10g/dl measured at screening
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 clinical trial voluntarily
Exclusion Criteria
- Patients who are expected to need dialysis within a year or patients with rapidly progressive chronic renal failure
- Patients who have received drug treatment such as erythropoiesis stimulating agent for the purpose of correcting anemia within 12 weeks prior to screening
- Patients who have received red blood cell transfusion within 12 weeks prior to screening
- Patients with uncontrolled hypertension
- Patients who had hypersensitivity to erythropoietin agents
- Patients who had known hypersensitivity to mammalian cell-derived products or additives
- Patients with history of severe cardiovascular diseases
- Patients whose anemia is not caused by chronic renal failure or may affect anemia correction including the following conditions:
- Patients whose AST/ALT test results performed at screening exceeds twice of normal upper limit
- Patients who have experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CKD-11101(Darbepoetin alfa)
NESP(Darbepoetin alfa)
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 reference drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Week 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 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
Ratio of subjects who achieve target level of hemoglobin: Compare the number of subjects who achieve target level of hemoglobin during the evaluation period between groups
Days taken to reach target level of hemoglobin
Days taken to achieve target level of hemoglobin: Compare days taken to achieve target level of hemoglobin between groups
Mean hemoglobin level for each week
Mean hemoglobin level for each week: Compare Weeks 4, 8, 12, 16, 20, 24, and 52 between groups
Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Compare the mean change of hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Ratio of subjects who receive transfusion
Ratio of subjects who receive red blood cell transfusion: Compare ratio of subjects who receive red blood cell transfusion during treatment period and evaluation period between groups
Full Information
NCT ID
NCT03431623
First Posted
January 29, 2018
Last Updated
February 12, 2018
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03431623
Brief Title
CKD-11101 Phase 3 SC Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 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 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.
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
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CKD-11101(Darbepoetin alfa)
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(Darbepoetin alfa)
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(Darbepoetin alfa)
Intervention Type
Biological
Intervention Name(s)
NESP(Darbepoetin alfa)
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 reference drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Week 0) will be conducted.
Time Frame
([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 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 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
Description
Ratio of subjects who achieve target level of hemoglobin: Compare the number of subjects who achieve target level of hemoglobin during the evaluation period between groups
Time Frame
Weeks 20 - 24
Title
Days taken to reach target level of hemoglobin
Description
Days taken to achieve target level of hemoglobin: Compare days taken to achieve target level of hemoglobin between groups
Time Frame
Days taken to reach up to 24 weeks
Title
Mean hemoglobin level for each week
Description
Mean hemoglobin level for each week: Compare Weeks 4, 8, 12, 16, 20, 24, and 52 between groups
Time Frame
Weeks 4, 8, 12, 16, 20, 24, and 52
Title
Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Description
Compare the mean change of hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Time Frame
Weeks 20, 24, and 52
Title
Ratio of subjects who receive transfusion
Description
Ratio of subjects who receive red blood cell transfusion: Compare ratio of subjects who receive red blood cell transfusion during treatment 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 chronic renal failure of stage 3 or above who are not on dialysis
Patients with the Hb levels of 8 to 10g/dl measured at screening
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 clinical trial voluntarily
Exclusion Criteria
Patients who are expected to need dialysis within a year or patients with rapidly progressive chronic renal failure
Patients who have received drug treatment such as erythropoiesis stimulating agent for the purpose of correcting anemia within 12 weeks prior to screening
Patients who have received red blood cell transfusion within 12 weeks prior to screening
Patients with uncontrolled hypertension
Patients who had hypersensitivity to erythropoietin agents
Patients who had known hypersensitivity to mammalian cell-derived products or additives
Patients with history of severe cardiovascular diseases
Patients whose anemia is not caused by chronic renal failure or may affect anemia correction including the following conditions:
Patients whose AST/ALT test results performed at screening exceeds twice of normal upper limit
Patients who have experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul-Woo Yang, M.D., Ph.D.
Organizational Affiliation
yangch@catholic.ac.kr
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30569763
Citation
Lee JH, Ha Chung B, Joo KW, Shin SK, Kim YL, Na KY, Do JY, Park SK, Shin BC, Lee JS, Kim YW, Kim SW, Lee KW, Kang GW, An WS, Shin GT, Han S, Yang CW. Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis. Curr Med Res Opin. 2019 Jun;35(6):1111-1118. doi: 10.1080/03007995.2018.1560134. Epub 2019 Jan 17.
Results Reference
derived
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CKD-11101 Phase 3 SC Study
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