Performance evaluation of ABH-PA

JRCT ID: jRCTs062190020

Registered date:15/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease
• Date of first enrollment: 13/01/2020
• Target sample size: 8
• Study type: Interventional
• Intervention(s): On-line hemodiafiltration therapy using ABH-22PA for six weeks.

Outcome(s)

• Primary Outcome: Reduction rate, Removal amount, Clear space, Albumin leakage, Transmembrane pressure, Antithrombotic property
• Secondary Outcome: Inflammatory response

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1) Patients on stable maintenance on-line hemodiafiltration therapy at least one month.
2) Patients with capable of obtaining blood flow rate >= 280 mL/min.
3) Patients who are undergoing hemodiafiltration with a hemodiafiler of membrane area >= 2.2m^2.
4) Patients who are undergoing hemodiafiltration for >= 4 hours per treatment.
5) Patients who are capable to participate in the study as outpatients.
6) Patients capable of understanding the informed consent form.
7) Patients >= 20 years and <85 years of age at the time of informed consent.

Exclude criteria

1)Patients requiring another blood purification therapy such as peritoneal dialysis other than
hemodiafiltration within this study period.
2)Patients with a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP).
3)Patients who will participate in other clinical trials that may influence the results of this study within this study period.
4)Patients in the opinion of the principal investigator to disqualify from participation.

Related Information

• Primary Sponsor: OKADA Kazuyoshi
• Secondary Sponsor: ASAHI KASEI MEDICAL CO., LTD