Skip to content

Anti-Thrombotic new membrane can Improve the Tendency of Blood Pressure down during HD Study

Anti-Thrombotic new membrane can Improve the Tendency of Blood Pressure down during HD Study - ATHRITE BP Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011872
Enrollment
50
Registered
2013-09-26
Start date
2013-09-26
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

Hypotension in hemodialysis

Interventions

Dialyzers will be changed to the dialyzer, Toraylight NV, having good biocompatibility on patients who need to treatment for hypotension during dialysis. Polysulfone(without NV) dialyzers will not be

Sponsors

ATHRITE BP Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Stable hemodialysis patients whose primary disease is diabetic nephropathy. (Patients have the dialysis vintage more than 1 year.) 2) The patients whose age is between 20 and 80 years at the time of enrollment in this study. 3) The patients who are using polysulfone dialyzers (PS, PES, PEPA) excluding NV series and VPS series. 4) The patients who receive treatment for hypotension induced by dialysis more than twice a month.

Exclusion criteria

Exclusion criteria: 1) A patient who is treated with other renal insufficiency therapies, continuous ambulatory peritoneal dialysis and hemodiafiltration, excluding hemodialysis. 2) A patient who is enrolled to other clinical study. 3) Cancer bearing patients. 4) A patient who has anamnestic cardiovascular diseases (heart attack, stroke) in less than 3 months. 5) A patient during infectious disease treatment. 6) A patient who is consider as onset of acute inflammation. 7) A patient who is a pregnant or intends to become a pregnant within one year. 8) A patient who is judged as the inadequate subject of this study by the doctor.

Design outcomes

Primary

MeasureTime frame
The event number of hypotension during dialysis is observed for 6 months on two groups of NV group and conventional DL group. (NV group; conventional dialyzers are changed to NV. Conventional DL group; conventional dialyzers are used continuously.)

Secondary

MeasureTime frame
1) Hemodynamics: Blood pressure at 0 and 240 minutes after the beginning of session, Catecholamine. 2) Dialysis dose: BUN (KT/V), Beta2-MG 3) Physique, electrolyte: BMI,Na,K,Cl,chest x-ray (CTR) 4) Ca, phosphate metabolism: P, Ca, int-PTH 5) Control anemia: Hb, EPO dose, serum ferritin 6) Nutritional status: serume Alb concentration. 7) Inflammatory status: high sensitive CRP, Pentraxin 3 8) Lipid: Total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol 9)Oxidative stress: Homocysteine, Pentosidine 10) Arteriosclerosis index: PWV, ABI

Countries

Japan

Contacts

Public ContactTsuchida Kenji

Kawashima Hospital Division of Nephrology, Endocrinology

ktsuchida@khg.or.jp088-631-0110

Outcome results

None listed

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