Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Taisho Pharmaceutical Co., Ltd.
Age
20–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Serum concentration of erythropoietin (EPO): \<50 mIU/mL at screening test 1, 2, or 3
Transferrin saturation ≥ 20% or ferritin ≥ 100 ng/mL at screening test 1
Subjects meeting any of the following criteria
1. Subjects who has not used erythropoiesis-stimulating agent (ESA) ≥ eight weeks from screening test 1
2. Subjects who has used ESA, other than epoetin beta pegol, ≥ four weeks from screening test 1 and has met all of the following criteria A) to C).
A)The total ESA dosage for each week could be changed within a range of 50%, compared to the total ESA dosage for one week before screening test 1, for four weeks before screening test 1 B)Acceptable to discontinue ESA the day following screening test 1 to Follow-up 2 C)The fluctuating range of Hb concentration between screening tests 1 and 2 is within ±0.5 g/dL per week (the same criteria applied between screening test 2 and 3)
Subjects who receive an explanation about the study before participating in the study and can understand the contents and are willing and able to provide written consent.
\<Criteria for ND subjects\>
CKD subjects who never received dialysis and do not need to receive dialysis during the study period.
Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to \< 13.0 g/dL.
Subjects with an eGFR at screening test 1 ≥ 15 mL/min/1.73m\^2 to \< 45 mL/min/1.73m\^2.
\<Criteria for HD subjects\>
Subjects who received hemodialysis (including diafiltration) three times per week ≥ 12 weeks from acquisition consent.
Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to \< 12.0 g/dL.
You may not be if
Subjects with anemia other than that caused by CKD.
Subjects who have severe infection, systemic hematopathy (e.g. myelodysplastic syndrome, hemoglobinopathy), peptic ulcer or clear hemorrhagic lesion such as gastrointestinal hemorrhage
Subjects with immune disorder with severe inflammation
Subjects with uncontrolled secondary hyperparathyroidism
Subjects who already had or will have a kidney transplantation
Subjects who have a complication which requires treatment such as proliferative retinopathy, macular edema, or macular degeneration. Or, subjects who had a complication which required treatment such as proliferative retinopathy, macular edema, or macular degeneration within 12 months from screening test 1
Subjects with congestive heart failure
Subjects with a medical history of thrombotic disease in the six months from screening test 1
Subjects with uncontrolled blood pressure; SBP \> 170 mmHg or DBP \> 100 mmHg at screening test 1 (ESA present, screening tests 1 and 2), (HD subject, evaluated before dialysis)
