This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
214
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
RECRUITINGMean Absolute Change in Hb levels
The primary endpoint is the mean absolute change in Hb levels between the screening/baseline period (Week -2 to Day 1 of Week 1) and the evaluation period (Week 21 to Week 24). Hb level at screening/baseline period is defined as the mean of the Hb measurements at screening and on Day 1 of Week 1 (prior to dosing). Hb level at evaluation period is defined as the mean of the Hb measurements at Week 21, 22, 23, and 24 (in detail, Day 1 of Week 21, Day 1 of Week 22, Day 1 of Week 23, and Day 1 of Week 24).
Time frame: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Hemoglobin Responder Rate
Time frame: Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24
Mean EPO dosage (Week 1 to Week 24)
Time frame: Week 1 ~ Week 24
Mean EPO dosage (Week 21 to Week 24)
Time frame: Week 21 ~ Week 24
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