Hypercholesterolemia, FamilialLINETNCT01753232
Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter
An observational study of Hypercholesterolemia, Familial and LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA, run by Fresenius Medical Care Deutschland GmbH at 11 sites in Germany.
Trial summary
Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Familial, LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
- What is being tested?
- DALI-adsorber and MONET-Lipoprotein filter
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 11 sitesGermany
- Study dates
- May 2012to Aug 2015
- Phase
- Observational
- 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
Study population: Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department
Who may be able to join
- given informed consent
- 18 years or older
- patient compliant to therapy as prescribed
- at least two therapy sessions per month
- treatment with DALI or MONET system for at least 3 months before inclusion
- last severe invasive intervention in hospital more than 3 months ago
Who cannot join
- earlier participation in the study
- unconscious patient/persons without capacity to contract
- for DALI: intake of ACE-inhibitors
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
Cologne, North Rhine-Westphalia, 51105
Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
Essen, North Rhine-Westphalia, 45127
Nephrologisches Zentrum Goettingen
Göttingen, Lower Saxony, 37075
Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering
Hanover, Lower Saxony, 30625
Apheresezentrum Ingelheim
Ingelheim, Rhineland-Palatinate, 55218
Medizinisches Versorgungszentrum
Kempten (Allgäu), Bavaria, 87439
Dialysezentrum Magdeburg-Stattfeld
Magdeburg, Saxony-Anhalt, 39108
Nierenzentrum Mannheim
Mannheim, Baden Würtemberg, 68309
Dialysezentrum Potsdam
Potsdam, Brandenburg, 14482
Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin
Regensburg, Bavaria, 93053
Apheresezentrum Rostock
Rostock, Mecklenburg-Vorpommern, 18059
About this study
Official title: Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter
Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.
Read the detailed description
Data were recorded from patients suffering from familial hypercholesterolemia and treated by lipid apheresis using one of the two systems investigated for at least 3 months prior to inclusion in the study. Only those treatments were documented in which routine blood samples for laboratory analysis were taken, or in which adverse or serious adverse device effects occur.
- Being tested
- DALI-adsorber, MONET-Lipoprotein filter
- Keywords
- DALI adsorber, MONET lipoprotein filter
- Medical subject headings
- Hyperlipoproteinemia Type II, Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DALI-adsorberDevice
Recording of treatment data. No extra interventional treatment
MONET-Lipoprotein filterDevice
Only treatment data recording. No extra interventional treatment
| Study group | Role | What they receive |
|---|---|---|
| DALI-adsorber, hypercholesterolemia | Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system Receives: Device: DALI-adsorber | |
| MONET-Filter, hypercholesterolemia | Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter Receives: Device: MONET-Lipoprotein filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Low Density Lipoprotein (LDL)-Concentration
Data are only recorded for visits with lab results
Measured: Every two weeks to every three months for 24 months
Secondary outcomes (16)
Blood/plasma volume treated
Measured: Every two weeks to every three months for 24 months
Number of occurence of adverse and serious adverse device effects
Measured: 24 months
Change of Lipoprotein(a)-concentration
Only in patients with isolated Lp(a) increase
Measured: Pre/post treatment over 24 months, once per month or every 3 months
Change of total cholesterol
Only for treatment sessions with lab results
Measured: Every two weeks to every three months for 24 months
Change of High Density Lipoprotein (HDL)-concentration
Only for treatment sessions with lab results
Measured: Every two weeks to every three months for 24 months
Change of triglyceride-concentration
Only for treatment sessions with lab results
Measured: Every two weeks to every three months for 24 months
Change in blood count
Only for treatment sessions with lab results
Measured: Every two weeks to every three months for 24 months
Change of fibrinogen-concentration
Only for treatment sessions with lab results
Measured: Every two weeks to every three months for 24 months
Change of creatinine-concentration
Measured: Every two weeks to every three months for 24 months
Change of Immunoglobulins (Ig)
Only for treatment sessions with lab results, Immunoglobulin (Ig) G, IgA and IgM if measured. In MONET patients only.
Measured: Every two weeks to every three months for 24 months
Change in C Reactive Protein (CRP)-concentration
Only for treatment sessions with lab results
Measured: Every two weeks to every three months for 24 months
Change of blood pressure and heart rate
Only for treatment sessions with lab results
Measured: Every two weeks to every three months for 24 months
Blood or plasma flow
Measured: Every two weeks to every three months for 24 months
Anticoagulation regime
Measured: Every two weeks to every three months for 24 months
Treatment time
Measured: Every two weeks to every three months for 24 months
Medication
Measured: Every two weeks to every three months for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia, FamilialStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Heinzler, MD, Principal investigator, Gemeinschaftspraxis Gysan, Heinzler, May, HossmannFranz Heigl, MD, Principal investigator, Dres. Heigl, Hettich & Partner Medizinisches VersorgungszentrumFrank Leistikow, MD, Principal investigator, Nierenzentrum MannheimFrido Himmelsbach, MD, Principal investigator, Apheresezentrum IngelheimRalf Spitthöver, MD, Principal investigator, Nephrologische Gemeinschaftspraxis Dialysezentrum/LipidzentrumEberhard Roeseler, MD, Prof, Principal investigator, Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort HeideringVolker Schettler, MD, Principal investigator, Nephrologisches Zentrum GoettingenGerd Schmitz, MD, Prof, Principal investigator, University Regensburg Department Clinical Chemistry and Laboratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753232
- Sponsor's protocol ID
- TA-DALI-MONET-01-D
- Acronym
- LINET
- Status last verified
- Sep 2015
- First submitted
- 13 Dec 2012
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter
- ClinicalTrials.gov ID
- NCT01753232
- Acronym / sponsor ID
- LINET / TA-DALI-MONET-01-D
- Keywords
- DALI adsorber, MONET lipoprotein filter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Dec 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.
Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.
Detailed description
Data were recorded from patients suffering from familial hypercholesterolemia and treated by lipid apheresis using one of the two systems investigated for at least 3 months prior to inclusion in the study. Only those treatments were documented in which routine blood samples for laboratory analysis were taken, or in which adverse or serious adverse device effects occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DALI-adsorber, hypercholesterolemia | – | Device: DALI-adsorberPatients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system |
| MONET-Filter, hypercholesterolemia | – | Device: MONET-Lipoprotein filterPatients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department
Key inclusion criteria (6 listed)
- given informed consent
- 18 years or older
- patient compliant to therapy as prescribed
- at least two therapy sessions per month
- treatment with DALI or MONET system for at least 3 months before inclusion
Key exclusion criteria (3 listed)
- earlier participation in the study
- unconscious patient/persons without capacity to contract
- for DALI: intake of ACE-inhibitors
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 |
|---|---|---|
| DALI-adsorberRecording of treatment data. No extra interventional treatment | Device | DALI-adsorber, hypercholesterolemia |
| MONET-Lipoprotein filterOnly treatment data recording. No extra interventional treatment | Device | MONET-Filter, hypercholesterolemia |
Primary outcome
Change of Low Density Lipoprotein (LDL)-Concentration
Time frame: Every two weeks to every three months for 24 months
Data are only recorded for visits with lab results
16 secondary outcomes
Blood/plasma volume treated
Time frame: Every two weeks to every three months for 24 months
Number of occurence of adverse and serious adverse device effects
Time frame: 24 months
Change of Lipoprotein(a)-concentration
Time frame: Pre/post treatment over 24 months, once per month or every 3 months
Change of total cholesterol
Time frame: Every two weeks to every three months for 24 months
Change of High Density Lipoprotein (HDL)-concentration
Time frame: Every two weeks to every three months for 24 months
Change of triglyceride-concentration
Time frame: Every two weeks to every three months for 24 months
Change in blood count
Time frame: Every two weeks to every three months for 24 months
Change of fibrinogen-concentration
Time frame: Every two weeks to every three months for 24 months
Change of creatinine-concentration
Time frame: Every two weeks to every three months for 24 months
Change of Immunoglobulins (Ig)
Time frame: Every two weeks to every three months for 24 months
Change in C Reactive Protein (CRP)-concentration
Time frame: Every two weeks to every three months for 24 months
Change of blood pressure and heart rate
Time frame: Every two weeks to every three months for 24 months
Blood or plasma flow
Time frame: Every two weeks to every three months for 24 months
Anticoagulation regime
Time frame: Every two weeks to every three months for 24 months
Treatment time
Time frame: Every two weeks to every three months for 24 months
Medication
Time frame: Every two weeks to every three months for 24 months
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 4 Sep 2015.
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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.
Rainer Heinzler, MD principal investigator
Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
Franz Heigl, MD principal investigator
Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum
Frank Leistikow, MD principal investigator
Nierenzentrum Mannheim
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, Familial and LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA, run by Fresenius Medical Care Deutschland GmbH at 11 sites in Germany.
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 6 inclusion and 3 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 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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?
Change of Low Density Lipoprotein (LDL)-Concentration (time frame: Every two weeks to every three months for 24 months). 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 4 Sep 2015.