Peritoneal Dialysis
Conditions
Interventions
Group A:take Roxadustat capsule
Group B:Recombinant human erythropoietin
Sponsors
the Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, body weight 40 to 100 kg; 2. Patients diagnosed with chronic kidney disease, renal anemia and undergoing peritoneal dialysis; 3. Hb values during the Screening Period must be <120 g/L; 4. Subjects must be on stable doses of IV or SC injections of rhEPO for at least 6 weeks prior to Day 1 (average dose <=15,000 IU/week); 5. Patients receiving rhEPO prior to enrollment must have an appropriate discontinuation period; 6. Subject has voluntarily signed an informed consent form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has the opportunity to ask questions; 7. Subjects agree not to start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from beginning of Screening Period through end of Follow-up Period.
Exclusion criteria
Exclusion criteria: 1. Have any other anemia caused by a disease other than CKD, such as thalassemia, sickle-cell anemia, tumor-associated anemia, chemotherapy-associated anemia, myelodysplastic syndrome, etc.; 2. Patients who have a history of severe drug allergies or are known to be allergic to the active ingredient or excipient of roxadustat; 3. Patients with severe liver damage (Child Pugh grade C) or active hepatitis; 4. Alanine aminotransferase (ALT) or aspartic aminotransferase (AST) >=3 ULN during screening visit; 5. Total bilirubin >=2 ULN during screening visit; 6. Women who are pregnant or breastfeeding; 7. Uncontrolled hypertension defined as two or more BP measurements within the Screening Period with systolic BP >180 mm Hg, or diastolic BP > 110 mm Hg; 8. The doctor judged a patient with a serious illness; 9. Patients with malignant tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| hepcidin;CRP;Iron series;Biochemical series;PTH; | — |
Countries
China
Contacts
Public ContactLI BING
the Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed