Renal Failure Chronic Requiring HemodialysisRevacom HDNCT01722695
Performance Comparison of Revaclear With Larger Dialyzer
A study testing Dialyzer comparison in people with Renal Failure Chronic Requiring Hemodialysis, run by Vantive Health LLC at 2 sites in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- Dialyzer comparison
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesAustria
- Study dates
- Nov 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Dialyseinstitut Prim. Dr. W. Gießauf GmbH
Graz, 8010
Medical University Graz
Graz, 8036
About this study
Official title: HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers
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
Read more
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
- Being tested
- Dialyzer comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialyzer comparisonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Revaclear followed by FX | Other | Not described Receives: Other: Dialyzer comparison |
| FX followed by Revaclear | Other | Not described Receives: Other: Dialyzer comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks (6 consecutive dialysis sessions)
Secondary outcomes (3)
Reduction rate of urea, creatinine, phosphate and ß2-microglobulin
Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).
Measured: 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.
Measured: 2 weeks (6 consecutive dialysis sessions)
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.
Measured: 2 weeks (6 consecutive dialysis sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Chronic Requiring HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Alexander Rosenkranz, Prof., Principal investigator, Medical University Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722695
- Sponsor's protocol ID
- 1499
- Acronym
- Revacom HD
- Status last verified
- Mar 2025
- First submitted
- 22 Oct 2012
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers
- ClinicalTrials.gov ID
- NCT01722695
- Acronym / sponsor ID
- Revacom HD / 1499
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revaclear followed by FX | Other | Other: Dialyzer comparison |
| FX followed by Revaclear | Other | Other: Dialyzer comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialyzer comparisonEach 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. | Other | FX followed by Revaclear, Revaclear followed by FX |
Primary outcome
Dialysis dose Kt/V urea
Time frame: 2 weeks (6 consecutive dialysis sessions)
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.
3 secondary outcomes
Reduction rate of urea, creatinine, phosphate and ß2-microglobulin
Time frame: 2 weeks (6 consecutive dialysis sessions)
Total removal of creatinine, phosphate and ß2-microglobulin
Time frame: 2 weeks (6 consecutive dialysis sessions)
Albumin loss
Time frame: 2 weeks (6 consecutive dialysis sessions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Rosenkranz, Prof. principal investigator
Medical University Graz, Austria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialyzer comparison in people with Renal Failure Chronic Requiring Hemodialysis, run by Vantive Health LLC at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis dose Kt/V urea (time frame: 2 weeks (6 consecutive dialysis sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.