Clinical characterization of hemodiafilter

JRCT ID: jRCTs032220723

Registered date:24/03/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease
• Date of first enrollment: 24/03/2023
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Perform online HDF using MFX-25SW eco, MFX-25UW eco, MFX-25S eco, and MFX-25U eco three times a week for 6 weeks.

Outcome(s)

• Primary Outcome: urea,creatinine,inorganic phosphorus,b2MG,a1MG,albumin

Secondary Outcome

(1) White blood cell count (rate of change before and after dialysis)
(2) Platelet count (rate of change before and after dialysis)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible for this study.
(1)Patients who have undergone online HDF for more than 1 month at the time of informed consent
(2)Patients who can maintain a stable blood flow rate of 280 mL/min
(3)Patients using a hemodiafilter with a membrane area of 2.5m2 or more
(4)Patients whose dialysis time is longer than 4 hours
(5)Patients who are ambulatory
(6)Patients who have given written informed consent to participate in this study
(7)Men and women aged 18 or over and under 85 at the time of obtaining consent

Exclude criteria

In consideration of the safety of the study subjects, patients who meet any of the following critria will be excluded from this study.
(1) Patients who need to take other blood purification therapies such as peritoneal dialysis that may affect the evaluation of research equipment during the research period
(2) Patients who have a history of acute symptoms such as anaphylactic reactions caused by polyethersulfone membranes or polyvinylpyrrolidone (PVP) in the past
(3) Patients participating in other clinical studies that may affect the results of this study during the research period
(4)Those with renal failure due to serious illness.
(5) Other patients ineligible whom the principal investigator deems to conduct this study

Related Information

• Primary Sponsor: Okada Kazuyoshi
• Secondary Sponsor: Nipro Corporation