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Clinical study of Hematide in chronic renal failure patients not on dialysis

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Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221002
Enrollment
Unknown
Registered
2010-02-12
Start date
2010-02-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal anemia

Interventions

investigational material(s) Generic name etc : Hematide INN of investigational material : Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for

Sponsors

Takeda Pharmaceutical Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)The subject has chronic renal failure and serum creatinine level of => 20 mg/dL at the screening period and not expected to start hemodialysis for at least 24 weeks after start of the study drug administration. 2)The subject has Hb level of 100 ng/mL, or with transferrin saturation of => 20% 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

Exclusion criteria: 1)The subject is known to be intolerant to 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.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026