Performance Comparison of Revaclear With Larger Dialyzer

Vantive Health LLC30 enrolled

Overview

The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area. Study design: open, randomized, cross-over, multicentric, controlled prospective Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on patient needs Patients/sample size: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions) with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers. Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss Primary variable: dialysis dose Kt/V urea Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin Safety variable: albumin loss, blood count

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Failure Chronic Requiring Hemodialysis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months * patients aged 18 years or more * written consent to participate in the study (informed consent) * dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate of at least 300 mL/min Exclusion Criteria: * single-needle dialysis * pregnant and lactating women * participation in other interventional studies less than 3 months prior to study start * non-compliance with the dialysis prescription * hematocrit less than 28% * hospitalization * antibiotic therapy * active infection * active cancer * known positive serology for HIV, hepatitis B or C * serious hemostasis disorders * any comorbidity possibly conflicting with the study purpose or procedures

Outcomes

Primary Outcomes

Dialysis dose Kt/V urea

Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure.

Time frame: 2 weeks (6 consecutive dialysis sessions)

Secondary Outcomes

Reduction rate of urea, creatinine, phosphate and ß2-microglobulin

Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).

Time frame: 2 weeks (6 consecutive dialysis sessions)

Total removal of creatinine, phosphate and ß2-microglobulin

Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.

Time frame: 2 weeks (6 consecutive dialysis sessions)

Albumin loss

Time frame: 2 weeks (6 consecutive dialysis sessions)

Performance Comparison of Revaclear With Larger Dialyzer

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes