Status:
COMPLETED
CKD-11101 Phase 3 SC Study
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 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, s...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT03431623
Start Date
May 1 2015
End Date
August 1 2017
Last Update
February 13 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.