Overview

This trial is active, not recruiting.

Conditions end stage renal disease, chronic kidney failure
Treatment allient system
Sponsor Renal Research Institute
Collaborator Renal Solutions, Inc.
Start date November 2008
End date February 2011
Trial size 40 participants
Trial identifier NCT00788905, 065-08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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).
allient system
The Allient System uses a different type of blood pump and a lower volume of dialysate.

Primary Outcomes

Measure
Clearance of specific waste products from blood determined through subject blood and dialysate samples
time frame: 3 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System
Principal investigator Nathan W. Levin, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Renal Research Institute.