Peritoneal dialysis patients
Conditions
Interventions
Change of therapy from epoetin beta-pegol to HIF-PH inhibitor, followed by 12 weeks of treatment
Continue treatment with epoetin beta-pegol for 12 weeks
Sponsors
International University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Peritoneal dialysis outpatients. 2) Patients from whom written informed consent was obtained.
Exclusion criteria
Exclusion criteria: Patients judged by the investigator to be unsuitable as subjects 1 Patients on concomitant hemodialysis (HD)or scheduled for HD during the institution. 2 Patients who developed peritonitis or catheter problems (e.g., tunnel infection) in the 4 weeks or more prior to the pre-examination and were considered to be interfering with the continuation of PD. 3 Patients with retinal neovascular lesions requiring treatment (e.g., proliferative diabetic retinopathy,exudative age-related macular degeneration,retinal vein occlusion)or macular edema requiring treatment. 4 Patients with inflammatory autoimmune diseases(systemic lupus erythematosus, rheumatoid arthritis,Sjogren's syndrome, celiac disease, etc.) that are thought to affect erythrocyte production. 5 Patients with a history of gastrointestinal resection(excluding gastric polypectomy and colorectal polypectomy)that may affect the absorption of drugs in the gastrointestinal tract or complicated by gastroparesis. 6 Patients with uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg in 1/3 of the measurements within 12 weeks prior to the pretest). 7 Patients with congestive heart failure (NYHA class 3 or higher) 8 Patients hospitalized for treatment of stroke, myocardial infarction or pulmonary infarction in the 12 weeks or more prior to the pre-examination 9 patients with positive hepatitis B virus surface HBs (antigens), hepatitis C virus (HCV)antibodies or human immunodeficiency virus (HIV) at the time of pretest. 10 Patients with anemia other than renal anemia (hemolytic anemia, pancytopenia, hemorrhagic anemia, etc.). 11 Patients scheduled for kidney transplantation during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transition of Hb, evaluated 12 weeks after assignment | — |
Secondary
| Measure | Time frame |
|---|---|
| Iron metabolism including hepcidin., evaluated 12 weeks after assignment | — |
Countries
Japan
Contacts
Public ContactTakahiro Kasai
Department of Medicine, International University of Health and Welfare nephrology
Outcome results
None listed