Chongqing technological innovation and application demonstration (social and people's livelihood) general project
Conditions
Interventions
Study arm:Roxadustat capsule
Sponsors
Department of Nephrology, DaPing Hospital of Army Medical University, ChongQing, China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has voluntarily signed and dated an informed consent form, approved by an Ethics Committee; 2. No gender limitation, Ages 18 to 80 years (inclusive); 3. Diagnosis of chronic kidney disease stage 3-5 patients with an estimated glomerular filtration rate (eGFR) between 10-60 mL/min/1.73m2 estimated using the CKD-EPI equation, Anemia was defined as hemoglobin (HB) < 120g / L; 4. Subject has not been treated with ESA, can comply with the research protocol; 5. A minimum body weight of 40 kg (inclusive); 6. More than 12 months eGFR data before enrollment.
Exclusion criteria
Exclusion criteria: 1. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic diseases such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition; 2. Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease); 3. New York Heart Association Class III or IV congestive heart failure at screening; 4. History of thromboembolic; 5. Women who are pregnant or breastfeeding; 6. Positive for human immunodeficiency virus antibody (HIV-Ab), or positive for hepatitis B surface antigen (HBsAg) and HBV NDA level higher than limits of detection, or positive for anti-hepatitis C virus antibody (HCV-Ab) and HCV RNA level higher than limits of detection, or a scheduled anti-virus treatment for HBV and HCV; 7. Any complex medical problems that may interfere study or increased risk, such as malignant tumors; 8. Allergic to the study drug (including active ingredients or excipients); 9. Unable to understand the potential risks and benefits of the study, no civil capacity; 10. Subjects who have participated in other drug clinical trials or are participating in other clinical trials within 4 weeks before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR;Serum creatinine; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;Serum lipid;liver function;Serum electrolyte;ferritin;Serum iron;Serum transferrin saturation; | — |
Countries
china
Contacts
Public ContactJie Yang
Outcome results
None listed