adult patients on hemodialysis
Conditions
Interventions
A single dose of NESP 5 microgram will be intravenously administered after hemodialysis to patients not receiving any ESAs for a period of 3 to 13 days. Pharmacokinetic data will be collected for 8
Sponsors
Medical Corporation Showakai Ikegami General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A voluntary written informed consent for the participation in the study 2) Aged >=20 and <80 years at providing the informed consent 3) Dry weight >=35 and <=70 kg measured on the nearest day before enrollment 4) Hemodialysis thrice weekly and a hemodialysis experience >=12 weeks by the time of enrollment 5) Intravenous treatment with recombinant human erythropoietin or darbepoetin alfa (weekly or biweekly dose <=40 microgram) for a period of >=12 weeks by the time of enrollment 6) Hemoglobin level of 9 to 12 g/dL measured on the nearest day before enrollment
Exclusion criteria
Exclusion criteria: 1) Complicated with congestive cardiac failure (New York Heart Association's Class III-IV) 2) Underwent a surgery requiring blood infusion, or blood collection >=200 mL (including blood donation and plasmapheresis donation) within 12 weeks before enrollment 3) Severe hepatic function disorder (aspartate aminotransferase or alanine aminotransferase >=100 U/L measured on the nearest day before enrollment) 4) Uncontrollable hypertension, or uncontrollable diabetes 5) Pregnant, lactating or possible pregnant at the time of enrollment, excluding amenorrhea >=12 months from the last menstruation. 6) Known serious allergy (including drug allergy). History or complication of addiction to drugs or alcohol. 7) Diagnosis and treatment history of malignant tumor occurred within 5 years before enrollment, excluding basal cell carcinoma and surgically resected in situ carcinoma of the cervix 8) Exposure to anabolic steroids, testosterone enanthate ester, mepitiostane, or epoetin beta within 12 weeks before enrollment 9) Exposure to any other investigational product within 12 weeks before enrollment 10) Ferritin <100 ng/mL and transferrin saturation <20% measured on the nearest day before enrollment 11) Known hypersensitivity to recombinant human erythropoietin or darbepoetin alfa 12) Patients ineligible for participation in the study as assessed by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Serum concentrations of darbepoetin alfa Pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessments | — |
Countries
Japan
Contacts
Public ContactAkiko Yamaguchi
Kyowa Hakko Kirin Co., Ltd. Medical Affairs Department
Outcome results
None listed