Status:
COMPLETED
Gambro AK200 ULTRA Hemodiafiltration Study
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Gambro Renal Products, Inc.
Baxter Healthcare Corporation
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodi...
Detailed Description
The AK200 ULTRA is a new device in the United States, but has been used for several years in Europe. The AK200 ULTRA is a single unit which is preprogrammed to provide standard hemodialysis as well as...
Eligibility Criteria
Inclusion
- Subject received chronic dialysis therapy
- Subject was stable on three dialysis sessions per week
- Subject was able to understand and sign the informed consent
Exclusion
- ) On chronic renal replacement therapy for less than three (3) months 2) Hospitalization for reasons other than vascular access complications in the past three (3) months 3) HIV + 4) Hepatitis B+ 5) Pregnancy, verified by pregnancy test for women of child bearing potential 6) Access recirculation \> 10% 7) Hematocrit less than 26% 8) History of non compliance 9) Pediatric patients, defined as less than 18 years old
Key Trial Info
Start Date :
August 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01202708
Start Date
August 1 1997
Last Update
March 11 2025
Active Locations (1)
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1
George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037