Chronic kidney disease
Conditions
Interventions
placebo group:Oral placebo
trace element group:Oral trace element
Sponsors
Yanbian Hospital, Affiliated Hospital of Yanbian University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. In line withKDIGO diagnostic staging criteria for chronic kidney disease; 3. End-stage renal disease and has received regular hemodialysis treatment 4. Within 1 month before screening, their weight, dialysis regimen and main medication were basically stable, and there was no major adjustment 5. Informed and voluntary participation in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who are currently undergoing acute dialysis or intermittent renal replacement therapy. Patients who are scheduled for kidney transplantation in the next 6 months and have found a matching donor 2. History of serious cardiovascular events such as unstable angina, acute myocardial infarction, severe arrhythmia, stroke or transient ischemic attack, acute heart failure (NYHA cardiac function class IV) within 6 months before screening. Poorly controlled severe hypertension (e.g., blood pressure persistent > 180/110 mmHg after dialysis). Active bleeding or clinically significant bleeding tendency. Confirmed malignancy (other than cured basal cell carcinoma of the skin or carcinoma in situ of the cervix) that is being treated or has an expected survival of < 1 year. 3. Active, uncontrolled serious infection (such as sepsis, active tuberculosis, active viral hepatitis, etc.). Positive human immunodeficiency virus antibody screen. Presence of active, uncontrolled autoimmune disease. 4. Severe gastrointestinal disease affecting drug absorption (e.g., Crohn's disease, ulcerative colitis), or recent (within 3 months prior to screening) active gastrointestinal bleeding. Severe malnutrition (e.g., subjective comprehensive nutrition rating of grade C) 5. Known allergy, specific reaction, or contraindication to the investigational drug or any of its excipients. Participated in clinical trials of other drugs or medical devices within 1 month before screening. Those who require the use of specific prohibited medications (such as strong CYP450 enzyme inhibitors/inducers) according to the requirements of the study protocol and cannot be discontinued during the trial. 6. Pregnant and lactating women, or subjects of childbearing age (regardless of gender) who plan to become pregnant during the study period and within 3 months after the end of the study, and are unwilling to take effective contraceptive measures. Have any history of mental or psychological illness that affects their understanding of informed consent or compliance with the study as judged by the investigator. In the opinion of the investigator, there are any other conditions that are not suitable for participation in this clinical trial (such as alcoholism, drug abuse, poor expected compliance, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Creatinine;Blood urea nitrogen;Cystatin C;Parathyroid hormone (PTH);hyperimmune C-reactive protein (CRP); | — |
Secondary
| Measure | Time frame |
|---|---|
| Ferrum (Fe);Total iron-binding capacity (TIBC);Uric acid (UA);White blood cell (WBC);Hemoglobin (Hb);Platelet (PLT);Neutrophil (NEUT);Lymphocyte (LYMPH);Calcium (Ca);Phosphorus (P);Carbon dioxide (CO2);Aspartate transaminase (AST);Alanine transaminase (ALT);cholinesterase (CHE);Alkaline phosphatase (ALP);Total protein (TP);albumin (ALB);Prealbumin (PA); | — |
Countries
China
Contacts
Public ContactZhenhua Cui
Yanbian Hospital, Affiliated Hospital of Yanbian University
Outcome results
None listed