Comparison of Conventional Dialysis and the Allient System

Renal Research Institute

Status: Unknown

Conditions: Chronic Kidney Failure; End Stage Renal Disease

Treatments: Device: Allient System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00788905

065-08

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 1 patient group

A

Experimental group

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).

Treatment:

Device: Allient System