Efficacy of erythropoietin beta pegol assessment study with kidney diseases.

Not Applicable

• Conditions: renal anemia

• Registration Number: JPRN-UMIN000007494
• Lead Sponsor: Kyoto University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-13
• Study Completion: 2017-04-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1. patients with uncontrolled hypertension (SBP >=180mmHg, DBP >= 110mmHg) 2. patients with critical cardiac and/or vascular complications 3. patients whose Hb level must be maintained less than 12.0 g/dL 4. patients who needs blood transfusion 5. patients with anemia other than renal anemia 6. patients with liver dysfunction [GPT(ALT) over three times the normal value] 7. patients with malignancies under current treatment 8. pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 9. patients with uncontrolled arrhythmia 10. patients with cardiac insufficiency (NYHA grade III or IV) 11. patients with a history of hypersensitivity to ingredients of epoetin alpha, epoetin beta, darbopoetin alpha 13. patients who are considered not eligible for the study by the attending doctor due to medical reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of maintaining the target Hb (over 11.0 g/dL)

Secondary Outcome Measures

Name	Time	Method
1. urinary 8-OHdG, small dense LDL, small dense LDL/LDL-C, oxidizedLDL, blood pressure, pulse rate, antihypertensive drugs, diuretics, antihyperlipidemic drugs, type of iron, dose of iron (0,2,12 month). 2. T-Cho, TG, HDL-C, LDL-C, LDL-C/HDL-C, eGFR, BNP (0,2,4,6,8,10,12 month) 3. Safety