Anemia of Chronic Kidney Disease
Conditions
Brief summary
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.
Interventions
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Only investigators will be blinded
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Glomerular Filtration Rate \<60 mL/min/1.73m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) * Hemoglobin (Hb) level in the range of ≥7 g/dL and \<10 g/dL at screening * Erythropoiesis Stimulating Agent (ESA) naïve subjects or previously treated subjects with ESA-free period of \>3 months (in case of pre-treatment with long-acting ESA such as pegylated epoetin, the long-acting ESA-free period of \>6 months)
Exclusion criteria
* Subjects who have received steady dialysis or subjects who are currently on dialysis * Subjects who have rapid progression of chronic renal failure (as per investigators' discretion; e.g., a GFR decrease of \>20% within 12 weeks prior to screening) * Subjects who have already undergone renal transplantation or who are scheduled for renal transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Change in Hb levels | Week -2~Week 1 (Prior to Dose), Week 1, Week 21, Week 22, Week 23, Week 24 | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin Responder Rate | 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) | Week 1 ~ Week 24 |
| Mean EPO dosage (Week 21 to Week 24) | Week 21 ~ Week 24 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety: Any adverse events | Week 1 to Week 52 | Any adverse events |
| Immunogenicity: Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2~Week 1 (Prior to Dose)) | (Week -2~Week 1 (Prior to Dose)), Week 52 | Anti-drug antibody (ADA) response by Week 52 compared to baseline (Week -2\ Week 1 (Prior to Dose)) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAyse Uslu
Outcome results
None listed