PMMA study

JRCT ID: jRCTs032200179

Registered date:29/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease undergoing hemodialysis
• Date of first enrollment: 24/05/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): To assess the adsorption properties of PMMA and PS membrane used for chronic kidney disease patients undergoing hemodialysis treatment.

Outcome(s)

Primary Outcome

Part 1. To identify the protein profile adsorbed on PMMA membrane with proteimic analyisis.
Part 2. To measure adsorption volume as well as reduction rate of beta2-microglobulin.

Secondary Outcome

Part 1. N/A
Part 2. To measure protein concentration adsorbed by PMMA membrane. Albumin, urea nitrogen, uric acid, creatinine, phosphate, beta2-microglobulin, alfa1-microglobulin, cystainC, leptin, myoglobin, prolactin, FLC kappa, FLC lamda, FGF-23, alfa1-glycoprotein, MMP-3, TNF-alfa, BTP, complement Factor D, HMGB-1, VEGF, YKL-40, visfatin, pentraxin-3, IL-6, IL-8, other molecules that are determined by proteomic analysis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 100age old
• Gender: Both

Include criteria

Patients who meet the all inclusion criteria as bellow,
1. Patients who can obtain written informed consent to participate in this study based on their free will.
2. Patients whose age is between 20 and 100 years old.
3. Patients undergoing hemodialysis treatment
4. Patients whose vascular access can keep blood flow more than 200 mL/minute
5. Patients who use hemodialyzer sized 1.5-2.5 m2
6. Patients with blood hemoglobin > 10 g/dL
7. Patients without heart failure

Exclude criteria

Patients who meet any exlusion criteria as bellow.
1. Patients who participate other clinical studies.
2. Patients who are pregnant.
3. Patients that the reseachers assess not suitable to join the study.

Related Information

• Primary Sponsor: Yamamoto Suguru
• Secondary Sponsor: Narita Ichiei
• Source(s) of Monetary Support: Toray Medical Co., Ltd.