Chronic kidney disease with anemia
Conditions
Interventions
Group A (Anemia treatment with erythropoietin, 10,000 units, intravenous/subcutaneous administration, continuous medication for not less than 3 months):N/A
Group B (Use erythropoietin for anemia treatment, other specifications, intravenous/subcutaneous administration, continuous medication for not less than 3 months):N/A
Group C (Anemia treatment using hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF, roxadustat), continuous medication for not less than 3 months):N/A
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Age >=18 years old; 2) Patients diagnosed with CKD stage 5 with anemia who need treatment; 3) Receive erythropoietin or roxadustat treatment; 4) Including the peridialysis period.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Serious lack of clinical data (missing >30% or some "important" clinical data, such as key drug names, etc.); 2) In addition to renal anemia, there is any other disease that causes chronic anemia (such as sickle cell anemia, hematological malignancy, hemolytic anemia, pure red blood cell aplasia), blood system disease or coagulation disorder, etc.; 3) Severe cardiovascular and cerebrovascular diseases, severe or unstable coronary artery disease, heart failure (NYHA class III or IV), myocardial infarction or stroke within 3 months before enrollment; 4) Medical history of malignant tumors, except for the following cases: basal cell or squamous cell carcinoma of the skin that has been cured or has no recurrence within 5 years, or carcinoma in situ at any site; 5) People with severe infectious diseases or chronic, uncontrollable inflammation; 6) Acute renal failure occurred during follow-up or was referred to other hospitals or lost to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of cardiovascular events (fatal cardiovascular disease, non-fatal myocardial infarction, non-fatal stroke, etc.) and thrombotic events (arterial-venous thrombosis, dialysis vascular access-related thrombosis, etc.);Peridialysis average hemoglobin (Hb) concentration and its change from baseline Hb concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality;;hospitalization rate of complications;The type, proportion and severity of adverse events (such as gastrointestinal bleeding, etc.;Changes in liver function, blood lipids and platelets compared with baseline;The number of dose adjustments of the subjects during the peridialysis period, and the proportion of subjects undergoing adjustments;The average weekly dose of drugs during the peridialysis period, and the average change of drug dosage before and after dialysis;The proportion of subjects receiving red blood cell transfusion during the peridialysis period, as well as the number and total amount of blood transfusion;Target Hb concentration maintenance ratio: the proportion of subjects whose average Hb concentration during the peridialysis period remains within the target range;Changes in the average value of other red blood cell indicators (reticulocytes, red blood cell count, mean red blood cell volume, mean red blood cell hemoglobin volume, mean red blood cell hemoglobin concentration, etc.) during the subject's observation period compared with the baseline value; | — |
Countries
China
Contacts
Public ContactChanglin Mei
Shanghai Changzheng Hospital
Outcome results
None listed