Maintenance dialysis patients who are indicated for hemodiafiltration.
Conditions
Interventions
Hemodiafiltration using AMPA-01
Sponsors
ASAHI KASEI MEDICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Maintenance dialysis patients corresponding to - three times per week - more than three and a half hours in each dialysis session - hemodialysis or hemodiafiltration for more than six months - last one month received hemodiafiltration. 2) Qb 250 mL/min is possible when the effectiveness evaluation. 3) Outpatients. 4) Ability to give written informed consent. 5) Aged 20 to <80 years at the time of informed consent.
Exclusion criteria
Exclusion criteria: 1) Need to blood purification other than AMPA-01. 2) With a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP). 3) Pregnant women or lactating mothers 4) With severe organ dysfunction other than kidney. 5) Patients who had participated in other clinical trial within the previous 6 months. 6) Judged ineligible by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The frequency of acute failure such as adverse events which is suspected to be caused by "AMPA-01". 2) Blood compatibility (Fluctuations in the number of white blood cells and platelets during hemodiafiltration.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) clearance 2) reduction rate 3) removal amount 4) protein leakage 5) transmembrane pressure | — |
Countries
Japan
Contacts
Public ContactOHSHIMA Koji
ASAHI KASEI MEDICAL CO., LTD. Clinical Development Department
Outcome results
None listed