Comparison of Conventional Dialysis and the Allient System

End Stage Renal Disease Clinical Trial

Official title:

Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00788905
• Other study ID #: 065-08
• Status: Unknown status
• Phase: N/A
• First received: September 23, 2008
• Last updated: March 27, 2013
• Start date: November 2008
• Est. completion date: January 2014

Study information

• Verified date: March 2013
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Failure
• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Device:
• Allient System
The Allient System uses a different type of blood pump and a lower volume of dialysate.

Locations

Country	Name	City	State
United States	Irving Place Dialysis Center	New York	New York
United States	Upper Manhattan Dialysis Center	New York	New York
United States	Yorkville Dialysis Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Renal Research Institute	Renal Solutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of specific waste products from blood determined through subject blood and dialysate samples		3 weeks
Secondary	Inflammation as determined by levels of specific inflammatory markers		3 weeks
Secondary	Red blood cell lifespan determined through a measurement of CO in the subject's breath		3 weeks