None listed
Conditions
Interventions
Medical Device : This clinical trial aims to compare the efficacy and safety of a trial dialysis filter device with a control filter device in patients undergoing hemodialysis three times a week. The
all other intervention aspects remain identical. The trial device is the Synoflux® Series by Synopex, and the control device is the FX classix Series by Fresenius Medical Korea (FMC), which has been a
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for this clinical trial are as follows, and only subjects who meet all the criteria below will be eligible to participate in the trial: 1) Adults aged 19 years or older 2) Individuals who have maintained stable hemodialysis three times a week for at least 3 months prior to study enrollment 3) Individuals who have voluntarily provided written informed consent after receiving an explanation of the purpose and methods of the clinical trial 4) Individuals who, in the investigator’s judgment, are able to participate in the study until its completion
Exclusion criteria
Exclusion criteria: The exclusion criteria for this clinical trial are as follows, and participants must not meet any of the criteria below to be eligible for participation: 1) Patients undergoing dialysis on a schedule other than three times a week 2) Patients receiving both peritoneal dialysis and hemodialysis 3) Patients scheduled or planned to switch to peritoneal dialysis or undergo a kidney transplant during the trial period 4) Individuals with residual renal function (patients whose daily urine output is 500 ml or more despite maintaining dialysis three times a week during screening) 5) Patients with a history of acute infection within four weeks prior to screening 6) Patients with the following conditions at the time of screening: - Active malignant tumors, including multiple myeloma or myelodysplastic syndrome (cancer) - Liver cirrhosis - HIV - Gammopathy - Bleeding disorders - Severe congestive heart failure, recent myocardial infarction, stroke, seizures, or thrombosis - Uncontrolled arrhythmias 7) Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use adequate contraception* * Adequate contraception is determined at the investigator’s discretion but may include the following examples: - Intrauterine device (IUD) - Tubal ligation and sterilization surgery - Condom or diaphragm with spermicide - Oral or other hormonal contraceptives (including injections, patches, mini-pills, or implants) 8) Individuals participating in other clinical trials 9) Any other individuals deemed unsuitable for participation in this trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| URR; Urea Reduction ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| Small molecule and middle molecule clearance rate;Dialysis adequacy (spKt/V);Safety endopoint (Adverse Event, Serum albumin retention rate, Symptoms during dialysis, etc.) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong Geun Kim
Inje University Sanggye Paik Hospital
Outcome results
None listed