chronic kidney disease
Conditions
Interventions
Test group:Roxadustat combined with oral iron supplements
control group:Roxadustat
Sponsors
Ya'an People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Meet the diagnostic criteria for end-stage renal disease, receive regular MHD treatment, and have been on hemodialysis for >= 3 months; 2) Patients who meet the diagnosis of renal anemia (hemoglobin value >= 80 and = 80 and= 1.2; 7) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) History of allergies or intolerance to the investigational drug; 2) Anemia caused by diseases other than renal anemia, such as hemolytic anemia, thalassemia, plasma cell proliferative anemia, and chronic hemorrhagic diseases; 3) Patients with severe infections, malignant tumors (excluding cancer patients who have been cured or relieved for >= 5 years), acute myocardial infarction, acute stroke, and those in the active phase of immune system diseases; 4) Pregnant or lactating women; 5) History of blood transfusion within one month; 6) Severe secondary hyperparathyroidism (iPTH >= 800pg/ml); 7) Severe heart failure (NYHA grade III or above) and poor control of hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 100mmHg); 8) Severe liver disease (ALT, AST and TBIL >= 2 times the upper limit of normal value) or hepatitis B surface antigen positive, or hepatitis C antibody positive; 9) Patients who have received synthetic metabolic steroids (such as androgens) within 12 weeks prior to the start of the treatment period or are expected to receive treatment during the treatment period; 10) It is expected that elective surgery will be performed on patients who experience significant blood loss during the study period; 11) Researchers expect patients who are unable to complete the trial course.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin;Hemoglobin response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Iron metabolism;Incidence of major cardiovascular and cerebrovascular adverse events in blood uric acid levels, MACCE; | — |
Countries
China
Contacts
Public ContactZheng Guangyi
Ya'an People's Hospital
Outcome results
None listed