Uremic phase of chronic renal failure (CKD5)
Conditions
Interventions
Test group:Endogenous Reinfusion Hemodialysis Filtration (HFR)
control group:Hemodialysis filtration (HDF)
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation and signing of informed consent form; 2.Age between 18-85 years old (including 18 and 85 years old), gender not limited; 3.It meets the diagnostic criteria of uremic phase of chronic renal failure (CKD5): the endogenous creatinine clearance (Ccr) is less than 10ml/min/1.73m^2, the Ccr of diabetes nephropathy is less than 15ml/min/1.73m^2, or the blood creatinine is more than 707umol/L; 4.Meets the diagnostic criteria for Chronic Kidney Disease Mineral and Bone Metabolism Disorders (CKD-MBD): Whole segment PTH level (measured by central laboratory)>300 pg/mL at screening; Blood phosphorus>1.45 mmol/l; 5.Chronic kidney failure patients with relatively stable conditions and meeting the indications for hemodialysis, who undergo maintenance hemodialysis for at least 3 months; 6.Liver function: AST and ALT = 1.5 times the upper limit of normal values, total bilirubin= 3.0 × 10^9/L, platelets >= 60.0 × 10^9/L, hemoglobin >= 60.0g/L; 8.Ability to communicate effectively with researchers and comply with the entire experimental requirements.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of allergy to endogenous re infusion hemodialysis (HFR) dialyzers in the past; 2.Acute infectious diseases in nearly half a month; 3.Repeated episodes of hypotension or hypertension with poor control (below 90/60 mmHg or above 200/100mmHg); 4.Severe active bleeding or anemia within the first 4 weeks of enrollment; 5.Uncontrollable or obvious heart disease, with myocardial infarction, obvious congestive heart failure, obvious supraventricular or ventricular arrhythmia, degree II or above heart block, acute myocardial ischemia or QT interval prolongation in the past 6 months; 6.Those with severe primary diseases such as severe heart, lung, nervous system diseases, severe liver diseases, diabetes ketoacidosis, hyperosmolar coma, and hematopoietic system, which doctors consider not suitable for inclusion; 7.The overall condition is extremely poor, with malignant tumors, active tuberculosis, limb defects, or extremely poor limb vascular conditions. 8.Less than 3 days after major surgery; 9.Elderly high-risk patients with mental illness; 10.Breastfeeding, pregnant women, and patients who wish to become pregnant or are at risk of becoming pregnant but do not use effective contraception by themselves or their spouses; 11.Researchers believe that there are patients with certain factors that may have a positive impact on this clinical trial; 12.Patients who have participated in clinical trials of other drugs within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iPTH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood phosphorus;blood calcium; | — |
Countries
China
Contacts
Public ContactXie Pan
The First Affiliated Hospital of Army Medical University
Outcome results
None listed