Japan Erythropoietin Treatment Study for Target Hb and Survival

Not Applicable

• Conditions: Renal anemia under hemodialysis

• Registration Number: JPRN-C000000254
• Lead Sponsor: Scientific Advisory Committee (SAC)

Brief Summary

Although erythropoiesis stimulating agents (ESA) may be beneficial for prolonging the survival of hemodialysis patients with anemia, association between hemoglobin (Hb) level and treatment outcome is still unclear, especially for the Japanese population. The Japan Erythropoietin Treatment (JET) Study, an open multi-center, prospective, observational study, was designed to evaluate the relationship between the maintenance of Hb levels and patient prognoses after the first administration of epoetin beta to new hemodialysis patients. Among a total of 10,310 patients, 6631 completed the initial 6 months of epoetin beta treatment (induction phase) and were followed up for a further 2.5 years (maintenance phase). Three-year survival rate of patients with <9 g/dL Hb levels after 6 months was 74.1%, which was significantly lower than 89.3% for patients with Hb levels 10-11 g/dL (reference group); the adjusted hazard ratio (HR) was 2.08 (95% CI, 1.57 to 2.77; p<0.0001). Moreover, the 3-year survival rate for poor responders with Hb levels <10 g/dL and weekly epoetin beta doses ≥9000 IU during the induction phase was 71.6%, which was significantly lower than 89.4% for the reference group, excluded poor responders and unstable responders, as a control group, and the HR was 1.71 (95% CI, 1.13 to 2.60; p=0.0118). Adverse events related to the treatment were reported in 71 of 10,310 patients (0.69%). These findings of the JET study indicate that the achieved low Hb levels and poor response to ESA therapy might be strongly associated with high mortality.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-01
• Study Completion: 2011-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
(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.