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Comparison of Conventional Dialysis and the Allient System

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ClinicalTrials.gov Identifier: NCT00788905
Recruitment Status : Unknown
Verified March 2013 by Renal Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2008
Last Update Posted : March 29, 2013
Sponsor:
Collaborator:
Renal Solutions, Inc.
Information provided by (Responsible Party):
Renal Research Institute

Brief Summary:
The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Chronic Kidney Failure Device: Allient System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System
Study Start Date : November 2008
Actual Primary Completion Date : February 2011
Estimated Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: A
Subject will continue conventional hemodialysis therapy for one week ("no intervention" phase) and then swtich to the Allient system for two weeks ("active comparator" phase).
Device: Allient System
The Allient System uses a different type of blood pump and a lower volume of dialysate.




Primary Outcome Measures :
  1. Clearance of specific waste products from blood determined through subject blood and dialysate samples [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Inflammation as determined by levels of specific inflammatory markers [ Time Frame: 3 weeks ]
  2. Red blood cell lifespan determined through a measurement of CO in the subject's breath [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Maintenance in-center hemodialysis
  • Age greater than or equal to 18 years
  • Has been on hemodialysis for at least 4 months
  • Uses a standard single-pass dialysis machine with a high-flux dialyzer

Exclusion Criteria:

  • Hospitalization during the 8 weeks preceding enrollment
  • Infection requiring antibiotic treatment during the 8 weeks preceding enrollment
  • Central venous cather as dialysis access
  • Uncontrollable blood coagulation anomalies
  • Smokers
  • Dialysis regimen other than 3 times weekly
  • In ability to understand the English language and give informed consent for participation in the study

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): NCT00788905


Locations
United States, New York
Irving Place Dialysis Center
New York, New York, United States, 10003
Upper Manhattan Dialysis Center
New York, New York, United States, 10025
Yorkville Dialysis Center
New York, New York, United States, 10128
Sponsors and Collaborators
Renal Research Institute
Renal Solutions, Inc.
Investigators
Principal Investigator: Nathan W. Levin, MD Renal Research Institute
Study Director: Peter Kotanko, MD Renal Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renal Research Institute
ClinicalTrials.gov Identifier: NCT00788905     History of Changes
Other Study ID Numbers: 065-08
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Renal Research Institute:
Hemodialysis

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