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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210608
Enrollment
7
Registered
2022-02-15
Start date
2022-02-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease undergoing hemodialysis

Interventions

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
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)
Renal dialysis
PMMA, adsorption, hemodiafiltration

Sponsors

Yamamoto Suguru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Clearance of alfa 1-microglobulin at 60 min after start of dialysis session

Secondary

MeasureTime frame
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.

Contacts

Public ContactSuguru Yamamoto

Niigata University Medical and Dental Hospital

yamamots@med.niigata-u.ac.jp+81-25-227-2200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026