Gambro AK200 ULTRA Hemodiafiltration Study

Chronic Renal Failure Clinical Trial

Official title:

Safety and Efficacy of Hemodiafiltration With On-Line Preparation of Substitution Fluid Using the Gambro AK 200 ULTRA System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202708
• Other study ID #: 070003
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: July 11, 2017
• Start date: August 1997

Study information

• Verified date: July 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 hemodialysis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• On line hemofiafiltration
hemodiafiltration with the Gambro AK 200 ULTRA
• On line hemodiafiltration
On line hemodiafiltration with the Gambro AK 200 ULTRA System

Locations

Country	Name	City	State
United States	George Washington University Medical Center	Washington, D.C.	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Renal Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Goal: To assess the safety and efficacy of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA for the treatment of chronic renal failure.		6 months