End Stage Renal Disease Clinical Trial
Official title:
Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System
Verified date | March 2013 |
Source | Renal Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Renal Research Institute | Renal Solutions, Inc. |
United States,
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 |
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