Comparison of Conventional Dialysis and the Allient System

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Renal Solutions, Inc.
Information provided by (Responsible Party):
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT00788905
First received: September 23, 2008
Last updated: March 27, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammation as determined by levels of specific inflammatory markers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Red blood cell lifespan determined through a measurement of CO in the subject's breath [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788905

Locations
United States, New York
Yorkville Dialysis Center
New York, New York, United States, 10128
Upper Manhattan Dialysis Center
New York, New York, United States, 10025
Irving Place Dialysis Center
New York, New York, United States, 10003
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

No publications provided

Responsible Party: Renal Research Institute
ClinicalTrials.gov Identifier: NCT00788905     History of Changes
Other Study ID Numbers: 065-08
Study First Received: September 23, 2008
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Renal Research Institute:
Hemodialysis

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

ClinicalTrials.gov processed this record on September 18, 2014