HemodialysisPhase 4NCT01534741
Comparison FX CorDiax 60 in Relation to the FX 60-Dialyzer
A Phase 4 study testing dialyzer comparison and Dialyzer in people with Hemodialysis, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- dialyzer comparison and Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Jul 2012
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are treated by post dilution on-line HDF for at least three months.
- Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks,
- Patients who are on a stable anticoagulation and anemia management,
- Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator,
- Patients who are on a regular thrice weekly HDF schedule,
- Patients who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min),
- Patients who are able to understand the nature and requirements of the clinical investigation and have given written informed consent,
- Patients who are aged 18 years or older.
Who cannot join
- Patients who do not meet the inclusion criteria,
- Patients with active HBV, HCV, HIV infection,
- Patients who are severely malnourished patients as judged by the principal investigator,
- Patients who are known or suspected to have allergy to the trial products or related products,
- Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages),
- Patients who have been diagnosed a current active malignant disease,
- Patients who participate simultaneously in another clinical investigation or in other clinical investigations during the last month,
- Patients who are uncooperative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer
Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type.
Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration.
Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
- Conditions
- Hemodialysis
- Being tested
- dialyzer comparison, Dialyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialyzer comparisonOther
Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.
DialyzerDevice
Comparison Dialyzer FX60 versus Cordiax60
| Study group | Role | What they receive |
|---|---|---|
| Dialyser | Active comparator | FX CorDiax 60 dialyzer Receives: Other: dialyzer comparison; Device: Dialyzer |
| FXDialyser | Active comparator | FX 60 dialyzer Receives: Device: Dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal rate of myoglobin
Measured: 2 weeks
Secondary outcomes (8)
Removal rate of urea
Measured: 2 weeks
Removal rate of phosphate
Measured: 2 weeks
Removal rate of ß2-microglobulin (ß2-m)
Measured: 2 weeks
Removal rate of prolactin
Measured: 2 weeeks
Removal rate of alpha1-microglobulin
Measured: 2 weeks
Removal rate of alpha1-acid glycoprotein
Measured: 2 weeks
Hematocrit pre and post-dialysis
Measured: 2 weeks
Albumin loss during dialysis session
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Responsible party
- Principal investigator, Francisco Maduell, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534741
- Sponsor's protocol ID
- HD-IIT-02-E
- Status last verified
- Jul 2012
- First submitted
- 10 Feb 2012
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maduell F, Arias-Guillen M, Fontsere N, Ojeda R, Rico N, Vera M, Elena M, Bedini JL, Wieneke P, Campistol JM. Elimination of large uremic toxins by a dialyzer specifically designed for high-volume convective therapies. Blood Purif. 2014;37(2):125-30. doi: 10.1159/000358214. Epub 2014 Mar 20.
PubMed 24662288
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. 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 FX CorDiax 60 in Relation to the FX 60-Dialyzer
- ClinicalTrials.gov ID
- NCT01534741
- Acronym / sponsor ID
- HD-IIT-02-E
- Conditions
- Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Feb 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.
Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type.
Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration.
Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialyser | Active comparator | Other: dialyzer comparison, Device: DialyzerFX CorDiax 60 dialyzer |
| FXDialyser | Active comparator | Device: DialyzerFX 60 dialyzer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who are treated by post dilution on-line HDF for at least three months.
- Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks,
- Patients who are on a stable anticoagulation and anemia management,
- Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator,
- Patients who are on a regular thrice weekly HDF schedule,
Key exclusion criteria (8 listed)
- Patients who do not meet the inclusion criteria,
- Patients with active HBV, HCV, HIV infection,
- Patients who are severely malnourished patients as judged by the principal investigator,
- Patients who are known or suspected to have allergy to the trial products or related products,
- Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages),
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 will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only. | Other | Dialyser |
| DialyzerComparison Dialyzer FX60 versus Cordiax60 | Device | Dialyser, FXDialyser |
Primary outcome
Removal rate of myoglobin
Time frame: 2 weeks
8 secondary outcomes
Removal rate of urea
Time frame: 2 weeks
Removal rate of phosphate
Time frame: 2 weeks
Removal rate of ß2-microglobulin (ß2-m)
Time frame: 2 weeks
Removal rate of prolactin
Time frame: 2 weeeks
Removal rate of alpha1-microglobulin
Time frame: 2 weeks
Removal rate of alpha1-acid glycoprotein
Time frame: 2 weeks
Hematocrit pre and post-dialysis
Time frame: 2 weeks
Albumin loss during dialysis session
Time frame: 2 weeks
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 9 Apr 2014.
- Results publication: PubMed 24662288Maduell F, Arias-Guillen M, Fontsere N, Ojeda R, Rico N, Vera M, Elena M, Bedini JL, Wieneke P, Campistol JM. Elimination of large uremic toxins by a dialyzer specifically designed for high-volume convective therapies. Blood Purif. 2014;37(2):125-30. doi: 10.1159/000358214. Epub 2014 Mar 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dialyzer comparison and Dialyzer in people with Hemodialysis, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 8 inclusion and 8 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 9 Apr 2014. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Removal rate of myoglobin (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534741, which also lists 1 linked publication.
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 9 Apr 2014.