Evaluation of the safety on hemodiafilter "AMPA-01" in renal failure patients.
Phase 3
- Conditions
- Maintenance dialysis patients who are indicated for hemodiafiltration.
- Registration Number
- JPRN-UMIN000017775
- Lead Sponsor
- ASAHI KASEI MEDICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1) clearance 2) reduction rate 3) removal amount 4) protein leakage 5) transmembrane pressure