Renal anemia in non-dialysis patients with chronic kidney disease
Conditions
Interventions
Experimental group:Roxadustat Capsules
Sponsors
The First Affiliated Hospital of Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) age 18-75 years old (inclusive), regardless of gender; 2) after the nature of the study was explained and subjects were allowed to ask questions about the study, they voluntarily signed an informed consent form approved by the Ethics committee; 3) patients with CKD stage 3-5 not receiving dialysis, estimated glomerular filtration rate (eGFR) =70 g/L and =40 kg; 6) subjects agreed not to add or change the current TCM (including dosage, frequency and brand) for anemia treatment from the start of screening to the end of follow-up.
Exclusion criteria
Exclusion criteria: 1) patients with New York Heart Association (NYHA) class III or IV congestive heart failure; 2) patients with a myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 26 weeks before the start of the treatment period; 3) patients with a previous history of malignancy, except for tumors that are determined to be cured or in remission for >=5 years, basal cell or squamous cell carcinoma of the skin that has been radically resected, or carcinoma in situ at any site; 4) any other anemia of the patient caused by diseases other than CKD, such as thalassemia, sickle cell anemia, pure red cell aplasia, cancer-related anemia, chemotherapy-related anemia, myelodysplastic syndrome, bleeding, malignant tumor, etc.; 5) patients with a life expectancy of =3× ULN and total bilirubin >=2×ULN; b) ALT or AST > 8×ULN; c) total bilirubin >=5×ULN; 8) patients with a history of severe drug allergy or known allergy to the active ingredient or excipients of roxadustat; 9) did not respond to treatment for renal anemia with roxadustat according to the investigator's judgment; 10) who used the trial drug or treatment within 28 days before initiation of treatment, enrolled in the investigational intervention, or who were expected to have legacy effects of the trial treatment for the duration of the study; 11) pregnant or lactating women, or women of childbearing potential who do not wish to use contraception; 12) any medical condition, such as active disease, clinically significant infection, decompensated cirrhosis, etc., that the investigator considers may pose a risk to the safety of the trial subject, may confound the evaluation of efficacy or safety, or may affect the participant's participation in the trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean Hb values during weeks 8-12;Proportion of subjects with mean Hb values in the range of 100 to 130g/L during weeks 8 to 12;Proportion of subjects with an increase in Hb level of at least 10g/L from baseline at weeks 8-12;Iron metabolism indicators (ferritin, serum iron, transferrin saturation, total iron binding) from week 8 to week 12 Lipid metabolism (cholesterol, low-density lipoprotein, triglyceride), C-reactive protein Change from baseline;The changes of Hb level and iron metabolism indexes in different inflammation levels (CRP > 4.9mg/L) from 8th to 12th week were compared with baseline;The proportion of subjects receiving salvage therapy (blood transfusion, ESAs therapy, intravenous iron) 5 weeks after the start of treatment and the time from the first dose to the occurrence of salvage therapy during the treatment period; | — |
Countries
China
Contacts
Public ContactFanna Liu
The First Affiliated Hospital of Jinan University
Outcome results
None listed