- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CKD-11101(Darbepoetin alfa)
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.
|
|
Active Comparator: NESP(Darbepoetin alfa)
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changed amount of mean hemoglobin level in evaluation period compared to the baseline
Time Frame: ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])
|
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 of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])
|
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24
Time Frame: 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.
|
Weeks 20 - 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratio of subjects who achieve target level of hemoglobin
Time Frame: Weeks 20 - 24
|
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
|
Weeks 20 - 24
|
Days taken to reach target level of hemoglobin
Time Frame: Days taken to reach up to 24 weeks
|
Days taken to achieve target level of hemoglobin: Compare days taken to achieve target level of hemoglobin between groups
|
Days taken to reach up to 24 weeks
|
Mean hemoglobin level for each week
Time Frame: Weeks 4, 8, 12, 16, 20, 24, and 52
|
Mean hemoglobin level for each week: Compare Weeks 4, 8, 12, 16, 20, 24, and 52 between groups
|
Weeks 4, 8, 12, 16, 20, 24, and 52
|
Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Time Frame: Weeks 20, 24, and 52
|
Compare the mean change of hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
|
Weeks 20, 24, and 52
|
Ratio of subjects who receive transfusion
Time Frame: Weeks 0 - 24
|
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
|
Weeks 0 - 24
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chul-Woo Yang, M.D., Ph.D., yangch@catholic.ac.kr
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 136Ane14005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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