Clinical study of Hematide in chronic renal failure patients on hemodialysis

Phase 2

• Conditions: Renal anemia

• Registration Number: JPRN-jRCT2080221071
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) The subject has been receiving hemodialysis prior to obtaining informed consent and clinically stable
2) The subjects has Hgb level of 10.0 g/dL or more and 12.0 g/dL or less during the screening phase
3) The subject has the serum ferritin level of 100 ng/mL or more, or with the transferrin saturation of 20 %or more at the screening phase
4) The subject is capable of giving consent to participation in the study and understanding the informed consent form and other explanatory documents, and has given written consent

Exclusion Criteria

1) The subject is known to be intolerant to any ESA
2) The subject is known to be intolerant to an iron preparation
3) The subject has received red blood cell or whole blood transfusion within 12 weeks (84 days) prior to the study drug administration
4) The subject has hemoglobinopathy (sickle cell disease, thalassemia, etc.)
5) The subject has any hemolytic disease or its past history
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified