Pharmacological clinical study on NESP 5 microgram(injection plastic syringe)

Not Applicable

• Conditions: adult patients on hemodialysis

• Registration Number: JPRN-UMIN000013805
• Lead Sponsor: Medical Corporation Showakai Ikegami General Hospital

Brief Summary

Refer to the article

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Serum concentrations of darbepoetin alfa Pharmacokinetic parameters

Secondary Outcome Measures

Name	Time	Method
Safety assessments