Safety and efficacy of monthly administration of darbepoetin alfa compared to the methoxy polyethylene glycol-epoetin beta in the treatment of anemia associated with chronic kidney disease in non-dialysis patients
Not Applicable
Recruiting
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0003999
- Lead Sponsor
- Soon Chun Hyang University Hospital Bucheon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
(1) Age (confirm at screening only): 18-99 years of age; (2) KDOQI CKD stages 4 or 5 using CKD Epidemiology collaboration (CKD-EPI) formula and were not on dialysis; (3) who had Hb 8 to 10 g/dL at baseline; adequate iron status (serum ferritin and transferrin saturation =100 ng/mL and =20%, respectively)
Exclusion Criteria
(1) Active cancer patients; (2) who was diagnosed decompensated liver cirrhosis and heart failure; (3) who had Arrhythmia, Asthma, COPD; adequate iron status (serum ferritin and transferrin saturation =100 ng/mL and =20%, respectively); (4) who have been treated erythropoietin stimulating agents (ESAs) previously; (5) who had history of GI bleeding, hemorrhage by trauma and menorrhagia; (6) pregnent woman
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mean change in Hb between baseline and efficaty evaluation period (EEP)
- Secondary Outcome Measures
Name Time Method (%) responders, defined as mean Hb within the Hb analysis range 10-11 g/dL during EEP;% time Hb in analysis range (10-11 g/dL) during the EEP