Clinical trial NCT01722695: Performance Comparison of Revaclear With Larger Dialyzer
Official title: HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Dialysatoren GmbH
name: Baxter Healthcare Corporation
First posted: 2012-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Dialysis dose Kt/V urea
timeFrame: 2 weeks (6 consecutive dialysis sessions)
Secondary outcomes:
measure: Reduction rate of urea, creatinine, phosphate and ß2-microglobulin
timeFrame: 2 weeks (6 consecutive dialysis sessions)
measure: Total removal of creatinine, phosphate and ß2-microglobulin
timeFrame: 2 weeks (6 consecutive dialysis sessions)
measure: Albumin loss
timeFrame: 2 weeks (6 consecutive dialysis sessions)
Other outcomes:
measure: Blood count
timeFrame: 2 weeks (start and end of 6 consecutive dialysis sessions)
Locations:
city: Graz
country: Austria
facility: Dialyseinstitut Prim. Dr. W. Gießauf GmbH
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
affiliation: Medical University Graz, Austria
name: Alexander Rosenkranz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: