Prognostic evaluation for renal anemia patients on hemodialysis based upon hemoglobin levels during treatment with Epoetin Beta Pegol: multicenter prospective study

Not Applicable

• Conditions: Renal anemia on hemodialysis

• Registration Number: JPRN-UMIN000010138
• Lead Sponsor: EP CRSU Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-01
• Study Completion: 2018-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

(randomized study part) (1) Anemia for other reasons than the renal anemia:Complication of apparent hemorrhagic lesion, hematologic disease (e.g. leukemia, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or apparent chronic inflammation (e.g. rheumatoid arthritis, inflammatory bowel disease) (2) Hypersensitivity to epoetin beta pegol, erythropoietin, or darbepoetin alfa (3) Complication of malignant tumor (4) Pregnancy, nursing or planning to become pregnant during the study (women only) (5) Judged as ineligible to the randomized study in the opinion of the investigator (observational study part) 1.Hypersensitivity to epoetin beta pegol, erythropoietin, or darbepoetin alfa 2.Pregnancy, nursing or planning to become pregnant during the study (women only) 3.Judged as ineligible to the randomized study in the opinion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular prognosis(randomized study part) Time to cardiovascular events such as cardiac death (death with heart failure, lethal myocardial infarction, sudden cardiac death), heart failure requiring hospitalization, and acute coronary syndrome (nonfatal myocardial infarction, unstable angina) requiring hospitalization. (observational study part) Cardiovascular events a. Relationship with ERI b. Relationship with iron

Secondary Outcome Measures

Name	Time	Method
(randomized study part) (1) Cardiovascular events (2) Death (3) Relationship between iron index and prognosis (4) Quality of life (5) Safety (observational study part) (1)Cerebrovascular events, composite events and total deaths a. Relationship with ERI b. Relationship with iron indices (2)Relationship between hemoglobin and cardiovascular events and cerebrovascular events (3)Safety