Japan Erythropoietin Treatment Study for Target Hb and Survival

UMIN ID: C000000254

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Renal anemia under hemodialysis
• Date of first enrollment: 2005/10/01
• Target sample size: 10000
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The relationship between maintenance Hb and vital prognosis (survival) at six months after the start of Epogin® Injection administration is investigated, and the optimal target Hb is established with respect to vital prognosis.

Secondary Outcome

(1) As with vital prognosis (survival), the optimal target Hb is investigated in relation to hospitalization. However, hospitalization due to testing or social purposes is excluded.
(2) The effects of erythropoietin therapy during the maintenance phase on vital prognosis and hospitalization following the initiation of dialysis are investigated.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female

Exclude criteria

1) Patients undergoing other types of dialysis – e.g., CAPD, HDF, or HF
2) Patients undergoing hemodialysis and another type of dialysis simultaneously
3) Patients who have undergone other types of dialysis prior to hemodialysis
4) Patients in whom dialysis has been terminated, then resumed
5) Patients who have received another erythropoietin preparation after initiation of hemodialysis
6) Patients who do not give informed consent

Related Information

• Primary Sponsor: Scientific Advisory Committee (SAC)
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO.LTD.