Back to resultsComparison of Conventional Dialysis and the Allient System
Primary Purpose
End Stage Renal Disease, Chronic Kidney Failure
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allient System
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis
Eligibility 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
Sites / Locations
- Irving Place Dialysis Center
- Upper Manhattan Dialysis Center
- Yorkville Dialysis Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
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).
Outcomes
Primary Outcome Measures
Clearance of specific waste products from blood determined through subject blood and dialysate samples
Secondary Outcome Measures
Inflammation as determined by levels of specific inflammatory markers
Red blood cell lifespan determined through a measurement of CO in the subject's breath
Full Information
NCT ID
NCT00788905
First Posted
September 23, 2008
Last Updated
March 27, 2013
Sponsor
Renal Research Institute
Collaborators
Renal Solutions, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00788905
Brief Title
Comparison of Conventional Dialysis and the Allient System
Official Title
Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renal Research Institute
Collaborators
Renal Solutions, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Chronic Kidney Failure
Keywords
Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Allient System
Intervention Description
The Allient System uses a different type of blood pump and a lower volume of dialysate.
Primary Outcome Measure Information:
Title
Clearance of specific waste products from blood determined through subject blood and dialysate samples
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Inflammation as determined by levels of specific inflammatory markers
Time Frame
3 weeks
Title
Red blood cell lifespan determined through a measurement of CO in the subject's breath
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan W. Levin, MD
Organizational Affiliation
Renal Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Kotanko, MD
Organizational Affiliation
Renal Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Irving Place Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Upper Manhattan Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Yorkville Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25710773
Citation
Rosales L, Thijssen S, Kruse A, Sipahioglu MH, Hirachan P, Raimann JG, Kuntsevich V, Carter M, Levin NW, Kotanko P. Inflammatory Response to Sorbent Hemodialysis. ASAIO J. 2015 Jul-Aug;61(4):463-7. doi: 10.1097/MAT.0000000000000212.
Results Reference
derived
Learn more about this trial
Comparison of Conventional Dialysis and the Allient System
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