Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients
- Conditions
- Peritoneal dialysis patients
- Registration Number
- JPRN-UMIN000040364
- Lead Sponsor
- International University of Health and Welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transition of Hb, evaluated 12 weeks after assignment
- Secondary Outcome Measures
Name Time Method Iron metabolism including hepcidin., evaluated 12 weeks after assignment