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Gambro AK200 ULTRA Hemodiafiltration Study

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ClinicalTrials.gov Identifier: NCT01202708
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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 hemodialysis.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Device: On line hemofiafiltration Device: On line hemodiafiltration Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hemodiafiltration With On-Line Preparation of Substitution Fluid Using the Gambro AK 200 ULTRA System
Study Start Date : August 1997
Actual Primary Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources


Intervention Details:
    Device: On line hemofiafiltration
    hemodiafiltration with the Gambro AK 200 ULTRA
    Other Name: Gambro AK 200 ULTRA
    Device: On line hemodiafiltration
    On line hemodiafiltration with the Gambro AK 200 ULTRA System
    Other Name: Gambro AK 200 ULTRA System


Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202708


Locations
United States, District of Columbia
George Washington University Medical Center
Washington, D.C., District of Columbia, United States, 20037
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Dr. Susie Q. Lew, MD George Washington University

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01202708     History of Changes
Other Study ID Numbers: 070003
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Baxter Healthcare Corporation:
chronic renal failure
hemodiafiltration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases