Post-dilution online hemodiafiltration using PMMA membrane in dialysis patients. A open-label and single arm study.

JRCT ID: jRCTs032210608

Registered date:15/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease undergoing hemodialysis
• Date of first enrollment: 15/02/2022
• Target sample size: 7
• Study type: Interventional

Intervention(s)

Hemodiafiltration treatment
Post-HDF-PMMA (high flow): Mode; post-dilution OL-HDF, Hemodiafilter; Filtrailzer HDF, Dialysate 450 mL/min, Filtration 50 mL/min, Quantity of blood 250 mL/min
Post-HDF-PMMA (low flow): Mode; post-dilution OL-HDF, Hemodiafilter; Filtrailzer HDF, Dialysate 470 mL/min, Filtration 30 mL/min, Quantity of blood 250 mL/min
Pre-HDF-PS: Mode; pre-dilution OL-HDF, Hemodiafilter; NVF-21M, Dialysate 300 mL/min, Filtration 200 mL/min, Quantity of blood 250 mL/min
Study schedule
Visit 1, 2, 3, 5, 6: Pre-HDF-PS
Visit 4: Post-HDF-PMMA (low flow)
Visit 7: Post-HDF-PMMA (high flow)

Outcome(s)

• Primary Outcome: Clearance of alfa 1-microglobulin at 60 min after start of dialysis session

Secondary Outcome

1. Effect
Removal rate and clearance of Alfa 1-microglobulin (except for the clearance at 60 minutes of treatment), Beta 2-microglobulin,urine nitrogen, cleatinine, phosphate, uric acid, interleukin 6, tumor necrosis factor alfa.
2. Safety
Change of blood pressure and pulse rate during hemodiafiltration treatment.
Transmembrane pressure during hemodiafiltration treatment.
Incidence of any diseases during the study period.
Mechanical troubles during hemodiafiltration treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• 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 more than 18 years old.
3. Patients undergoing pre-dilution hemodiafiltration with NVF-21M hemodiafilter.
4. Patients whose vascular access can keep blood flow more than 250 mL/minute
5. Patients who do not have redisual kidney function.

Exclude criteria

Patients who meet any exlusion criteria as bellow.
1. Patients who participate other clinical studies.
2. Patients who are pregnant or want pregnancy.
3. Patients with blood hemoglobin level <10 g/dL.
4. Patients with severe heart failure.
5. Patients who needed to change quantity of blood during dialysis treatment owing to worse of circulation in recent three sessions.
6. Patients that the investigators decide inappropreate to join the study.

Related Information

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