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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01722695
Other study ID # 1499
Secondary ID
Status Completed
Phase N/A
First received October 22, 2012
Last updated March 5, 2018
Start date November 2012
Est. completion date December 2012

Study information

Verified date March 2018
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Austria Dialyseinstitut Prim. Dr. W. Gießauf GmbH Graz
Austria Medical University Graz Graz

Sponsors (2)

Lead Sponsor Collaborator
Baxter Healthcare Corporation Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Other Blood count Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L). 2 weeks (start and end of 6 consecutive dialysis sessions)
Primary 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. 2 weeks (6 consecutive dialysis sessions)
Secondary Reduction rate of urea, creatinine, phosphate and ß2-microglobulin Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%). 2 weeks (6 consecutive dialysis sessions)
Secondary 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. 2 weeks (6 consecutive dialysis sessions)
Secondary Albumin loss 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. 2 weeks (6 consecutive dialysis sessions)
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