Performance Comparison of Revaclear With Larger Dialyzer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Renal Failure Chronic Requiring Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Revaclear followed by FX

Group Type OTHER

Dialyzer comparison

Intervention Type OTHER

Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX).

The order of dialyzers used will be randomly assigned to the patient at randomization.

FX followed by Revaclear

Group Type OTHER

Dialyzer comparison

Intervention Type OTHER

Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX).

The order of dialyzers used will be randomly assigned to the patient at randomization.

Interventions

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Dialyzer comparison

Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX).

The order of dialyzers used will be randomly assigned to the patient at randomization.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No