A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).
- Conditions
- Chronic kidney disease anemia
- Registration Number
- JPRN-UMIN000008505
- Lead Sponsor
- Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
- Brief Summary
Office/ambulatory BP, renal function, and other parameters were not significantly different between groups. Although office/ambulatory BP profiles had not worsened after 24 weeks of ESA treatment, more than half of the patients required an increase in the antihypertensive agent dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood pressure variability(clinical BP, pulse rate, central blood pressure, PWV, pulse pressure, CAVI, ABPM)
- Secondary Outcome Measures
Name Time Method 1.Cardio vascular events 2.Hemoglobin 3.Estimated GFR 4.Serum creatinine 5.Proteinuria 6.Dialysis initiation 7.Renal transplantation 8.mortality