Gambro AK200 ULTRA Hemodiafiltration Study

Vantive Health LLC

Status: Completed

Conditions: Chronic Renal Failure

Treatments: Device: On line hemodiafiltration; Device: On line hemofiafiltration

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202708

070003 (Other Identifier)

Details and patient eligibility

About

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 hemodialysis.

Full 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 hemofiltration and hemodiafiltration with on-line preparation of the substitution fluid The AK200 ULTRA hemofiltration and hemodiafiltration is performed using a high flux membrane with high ultrafiltration rates compensated by volumetrically controlled infusion of on-line prepared substitution fluid. The AK200 ULTRA is, therefore, capable of providing dialysis treatments which can improve the removal of medium to high weight molecules without the difficulties associated with the manual measurement and administration of external substitution fluid.

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 hemodialysis. This study is motivated by the need for a commercially available product capable of administering hemofiltration and hemodiafiltration in a clinical setting. The ultimate goal of this study is to improve morbidity and mortality in the ESRD patient population in the United States.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject received chronic dialysis therapy
2. Subject was stable on three dialysis sessions per week
3. Subject was able to understand and sign the informed consent

Exclusion criteria

) 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)