Status:
COMPLETED
CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT03428594
Start Date
June 1 2015
End Date
June 1 2017
Last Update
February 9 2018
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