CKD anemia
Conditions
Interventions
Case series:Nil
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Subject has voluntarily signed and dated an informed consent form, approved by an Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions; 3. CKD anemia patients who are on Roxadustat (prevalent) treatment or could be treated by Roxadustat (incident) based on investigators judgement*. *Treatment should be performed after investigators careful assessment of the patient's risk/benefit. According to national CKD anemia treatment guidelines, hemoglobin level should be = 6 weeks.)
Exclusion criteria
Exclusion criteria: 1. Any other anemia caused by conditions other than CKD, e.g., thalassemia, sickle cell anemia, pure red cell aplasia, myelodysplastic syndrome, bleeding, malignancy etc. 2. Patients with medical history of serious drug allergy or known history of allergy to the active ingredients or excipients of Roxadustat; 3. Women who are pregnant or breastfeeding or women of childbearing potential who are not willing to use appropriate contraception; 4. Life expectancy of = 3 ULN and total bilirubin >= 2 ULN; (2) ALT or AST > 8 ULN; (3) Total bilirubin >= 5 ULN; 6. Patients who are participating in or will participate in an investigational interventional study during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment-emergent adverse events;serious adverse events;adverse events of interest;Changes from baseline in vital signs, ECG findings, and selected clinical laboratory values; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin;SF-36 Vitality subscale score;SF-36 Physical Functioning subscale score;RAPA self-reported Physical Activity score; | — |
Countries
China
Contacts
Public ContactJianghua Chen
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed