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Comparison of Conventional Dialysis and the Allient System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Renal Research Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788905
First Posted: November 11, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Renal Solutions, Inc.
Information provided by (Responsible Party):
Renal Research Institute
  Purpose
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 Intervention
End Stage Renal Disease Chronic Kidney Failure Device: Allient System

Study Type: Interventional
Study Design: 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

Further study details as provided by Renal Research Institute:

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

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

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: January 2014
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: September 23, 2008
First Posted: November 11, 2008
Last Update Posted: October 12, 2017
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