Renal Failure Chronic Requiring HemodialysisNCT01578421
Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser
A study testing 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) in people with Renal Failure Chronic Requiring Hemodialysis, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
The purpose of the study is to compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration. 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?
- 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 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
- hemodialysis patients 18 years and older
- treated by post dilution on-line Hemodiafiltration (HDF) for at least one month
- who reached a dialysis dose (Kt/V) of at least 1.2 at each of the last two monthly checks
- who are on a stable anticoagulation and anemia management
- whose hemoglobin is between 10.5 and 13.0 g/dl
- who are clinically stable based on judgment of nephrologist
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- who are on a regular thrice weekly HDF schedule, e.g. Monday-Wednesday-Friday or Tuesday-Thursday-Saturday,
- who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min)
- who are able to understand the nature and requirements of the clinical investigation and who have given written informed consent
Who cannot join
- with active Hepatitis B, Hepatitis C or HIV infection
- who are severely malnourished as judged by the principal investigator
- who are known or suspected to have allergy to the trial products or related products
- with a central venous catheter based vascular access
- who are abusing non-legal drugs or alcohol
- who have currently active malignant disease
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- who are female of child-bearing age without effective measures of contraception, pregnant or breastfeeding
- who participate simultaneously in another clinical investigation
- who have participated in othe clinical investigations during the last month
- who are uncooperative
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration.
- Being tested
- 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)Device
4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements
| Study group | Role | What they receive |
|---|---|---|
| FX 100 dialyzer | Other | Not described Receives: Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) |
| Polyflux 210 H dialyzer | Other | Not described Receives: Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) |
| FXCorDiax 100 dialyzer | Other | Not described Receives: Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance and removal rate of phosphate, beta2 microglobulin and leptin
during a 4 hour online hemodiafiltration session
Measured: 4 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Responsible party
- Principal investigator, Andreas Bock, Kantonsspital Aarau
- Investigators
- Andreas Bock, MD, Principal investigator, Nephrology Division, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578421
- Sponsor's protocol ID
- HD-FX-01-CH
- Status last verified
- Aug 2013
- First submitted
- 12 Apr 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser
- ClinicalTrials.gov ID
- NCT01578421
- Acronym / sponsor ID
- HD-FX-01-CH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Apr 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 compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FX 100 dialyzer | Other | Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) |
| Polyflux 210 H dialyzer | Other | Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) |
| FXCorDiax 100 dialyzer | Other | Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- hemodialysis patients 18 years and older
- treated by post dilution on-line Hemodiafiltration (HDF) for at least one month
- who reached a dialysis dose (Kt/V) of at least 1.2 at each of the last two monthly checks
- who are on a stable anticoagulation and anemia management
- whose hemoglobin is between 10.5 and 13.0 g/dl
Key exclusion criteria (10 listed)
- with active Hepatitis B, Hepatitis C or HIV infection
- who are severely malnourished as judged by the principal investigator
- who are known or suspected to have allergy to the trial products or related products
- with a central venous catheter based vascular access
- who are abusing non-legal drugs or alcohol
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 |
|---|---|---|
| 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements | Device | FX 100 dialyzer, FXCorDiax 100 dialyzer, Polyflux 210 H dialyzer |
Primary outcome
Clearance and removal rate of phosphate, beta2 microglobulin and leptin
Time frame: 4 hour
during a 4 hour online hemodiafiltration session
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 7 Aug 2013.
- Website of the Kantonsspital Aarau Nephrology DivisionLink provided by the sponsor.
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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.
Andreas Bock, MD principal investigator
Nephrology Division, Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax) in people with Renal Failure Chronic Requiring Hemodialysis, run by Kantonsspital Aarau at 1 site in Switzerland.
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 9 inclusion and 10 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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Clearance and removal rate of phosphate, beta2 microglobulin and leptin (time frame: 4 hour). 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 7 Aug 2013.