A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).

A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD). - A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008505

Enrollment

Registered

2012-07-23

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

Chronic kidney disease anemia

Interventions

Epoetin beta pegol groups: Patients are initially given 25-250 micrograms of epoetin beta pegol once a month for 48 weeks. darbepoetin alpha groups: Patients are initially given 60-180 micrograms of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Pre-dialysis chronic kidney disease 2.20 years and over 3.Above 40 kg, below 80 kg 4.estimated GFR<60 ml/min/1.73m2 (within 12 weeks) 5.TSAT=>20% (within 4 weeks) 6.Hemoglobin level<=11.0g/dL (within 8 weeks) 7.Patients who have not recieved rHuEPO within 12 weeks

Exclusion criteria

Exclusion criteria: 1.Severe hypertension(diastolic blood pressure is over 100 mmHg within 12 weeks) 2.Congestive heart failure(NYHA class3, 4) 3.Pregnant women and/or women who are suspect of pregnancy 4.History or complication of cardiac infarction, pulmonary embolism or symptomatic cerebral infarction 5.History of hypersensitivity to epoetin beta pegol and/or darbepoetin alpha 6.Patients with malignancy, severe infection, systemic blood disease(MDS, etc.), hemolytic anemia or hemorrhagic disease 7.Administration of anabolic steroids, testosterone enanthate or mepitiostane within 12 weeks 8.Erythrocyte transfusion within 16 weeks 9.Patients who will plan to undergo a severe bleeding surgery 10.Patients judged as inappropriate for the study

Design outcomes

Primary

Measure	Time frame
Blood pressure variability(clinical BP, pulse rate, central blood pressure, PWV, pulse pressure, CAVI, ABPM)	—

Secondary

Measure	Time frame
1.Cardio vascular events 2.Hemoglobin 3.Estimated GFR 4.Serum creatinine 5.Proteinuria 6.Dialysis initiation 7.Renal transplantation 8.mortality	—

Countries

Japan

Contacts

Public ContactKouichi TAMURA

Yokohama City University School of Medicine Department of Cardiorenal Medicine

tamukou@med.yokohama-cu.ac.jp045-787-2635

Outcome results

None listed

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