Phase
Condition
N/ATreatment
hemoperfusion combined with hemodialysis
regular hemodialysis
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-80 years, regardless of gender
Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysispattern
Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours perweek, vascular access unlimited
Blood β2-MG > 30 mg/L and/or 300 pg/ml < immunoreactive parathyroid hormone (iPTH) < 800 pg/ml and/or CRP ≥ 16.2 pg/ml
Kt/V ≥ 1.2 eight weeks prior to enrollment
Signed informed consent form
Exclusion
Exclusion Criteria:
Known allergic reaction, contraindication or intolerance to the material of thedialyzer or perfusion apparatus
Test indicators meeting one or more of the following: white blood cell <4 x 10^9/L,platelet count <60 x 10^9/L, serum albumin <30 g/L
Blood flow <200 ml/min
Regular hemoperfusion treatment for more than 3 months and at least once every 2weeks
Active bleeding or chronic gastrointestinal bleeding, or other severe bleedingtendencies or coagulation disorders
History of unstable angina pectoris, myocardial infarction, severe arrhythmia,pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in thelast 8 weeks
Cerebral hemorrhage in the last 12 weeks
Severe heart failure (New York Heart Association class IV)
Acute infection, acute or critical illnesses such as severe cardiac, pulmonary,hepatic or neurological disease and malignancy
Pregnancy or breastfeeding
Participation in a clinical trial or ongoing clinical trial within 3 months
Expected survival of less than 1 year
Not considered suitable for participation in this trial by the investigator
Study Design
Study Description
Connect with a study center
Changhai Hospital
Shanghai, Shanghai 200433
ChinaActive - Recruiting
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