Performance Comparison of Revaclear With Larger Dialyzer

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

— Revacom HD  

Official title:

HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722695
• Other study ID #: 1499
• 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
• 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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis
• Renal Insufficiency

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)