Efficacy of erythropoietin beta pegol assessment study with kidney diseases.

Efficacy of erythropoietin beta pegol assessment study with kidney diseases. - EPACME Study (ErythroPoietin Assessment in CKD patients by Metabolic and Endocrinological factors)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007494

Enrollment

100

Registered

2012-03-13

Start date

2012-07-01

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

Epoetin beta pegol 25-250 microg/2-8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients with renal anemiaa 2. patients with CKD stage 3-5 3. patients without dialysis 4. patients without renal transplantation 5. outpatient 6. patients with informed consent 7. patients are enrolled on trial with two groups (non-diabetic and diabetic groups)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage of maintaining the target Hb (over 11.0 g/dL)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactHideki Yokoi

Kyoto Univesity Graduate School of Medicne Department of Nephrology

yokoih@kuhp.kyoto-u.ac.jp075-751-4420

Outcome results

None listed

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