Direct hemoperfusion with PMMA to adsorb uremic toxins in hemodialysis patients

JRCT ID: jRCT1032230028

Registered date:16/04/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Chronic kidney disease undergoing hemodialysis
Dialysis-related amyloidosis

• Date of first enrollment: 10/03/2023
• Target sample size: 10
• Study type: Observational

Outcome(s)

• Primary Outcome: The removal rate of beta2-m with FT-75 and FT-145 for 240 min.
• Secondary Outcome: The removal rate of beta2-m with FT-75 and FT-145 for 30, 60, and 120 min. The removal rate of alfa1-m with FT-75 and FT-145 for 30, 60, 120, and 240 min. The removal rate of beta2-m and alfa1-m with dialyzer for 30, 60, 120, and 240 min. The clearance of beta2-m and alfa1-m with dialyzer for 30, 60, 120, and 240 min. Safety for allergy, blood pressure, white blood cell, and platelet count.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all the inclusion criteria below,
1. Patients who can obtain written informed consent to participate in this study based on their free will.
2. Patients who are more than 18 years old.
3. Patients undergoing hemodialysis treatment for 4 hours/session and three times a week.
4. Patients with dialysis-related amyloidosis have the criteria to use FT-75 and FT-145.
5. Patients who do not have residual kidney function.
6. Patients with systolic blood pressure at pre-dialysis over 100 mmHg.
7. Patients whose blood hemoglobin at pre-dialysis is more than 10.5 g/dL.

Exclude criteria

Patients who meet any exclusion criteria are below.
1. Patients who participate in other clinical studies.
2. Patients who are pregnant or want pregnancy.
3. Patients that the investigators decide are inappropriate to join the study.

Related Information

• Primary Sponsor: Yamamoto Suguru
• Source(s) of Monetary Support: TORAY MEDICAL CO,.LTD.