Hypercholesterolemia, FamilialDIAMOND-2018NCT03795038
Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI
A study testing Lipoprotein Apheresis MONET and DALI and Lipoprotein Apheresis DIAMED and DALI in people with Hypercholesterolemia, Familial and Dyslipidemias, run by Fresenius Medical Care Deutschland GmbH at 2 sites in Germany.
Trial summary
The clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Familial, Dyslipidemias, Cardiovascular Diseases
- What is being tested?
- Lipoprotein Apheresis MONET and DALI and Lipoprotein Apheresis DIAMED and DALI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 28 Dec 2018to 25 May 2021
- 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
- Informed consent signed and dated by study patient and investigator/authorised physician
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study
- Study-specific inclusion criteria:
- Patients with indication for lipoprotein apheresis confirmed by a local apheresis expert commission according to the German guidelines [1] and with routine lipoprotein apheresis treatments for at least 3 months. Patients with weekly treatments have not missed more than 3 treatment sessions within the 3 months prior inclusion to the study. Patients with biweekly treatment sessions have not missed more than 1 treatment session within the 3 months prior inclusion to the study
- Patients with regular weekly or biweekly lipoprotein apheresis treatments with either MONET or DIAMED lipoprotein apheresis systems for at least 4 weeks (weekly treatments) or 8 weeks (biweekly treatments) with the same system
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- With adequate venous access
- With systolic blood pressure > 100 mmHg
- With stable hematocrit >35 %
- With stable anticoagulation
Who cannot join
- Any condition which could interfere with the patient's ability to comply with the study
- Pregnancy or lactation period (pregnancy test will be conducted with female patients aged 55 years)
- Participation in an interventional clinical study during the preceding 30 days or in the same study
- Study-specific exclusion criteria:
- Occurrence or clinical relevant deterioration of acute myocardial infarction, unstable angina pectoris, severe hemo-dynamic relevant arrhythmia within 3 months prior inclusion to the study
- Bypass surgery, vascular diseases, active infection (this means chronic infectious diseases (e.g. chronic hepatitis) and acute infections with a core body temperature ≥ 38.0 °C) or unstable circulation (see exclusion criteria no. 7) within the last 3 months
Show all 10Show fewer
- Uncontrolled high or low blood pressure defined as systolic blood pressure >180 mmHg/<100 mmHg and/or diastolic blood pressure >115 mmHg (after three times measuring)
- Changes in lipid lowering medication within the last 2 weeks
- Intake of Angiotensin Converting Enzyme (ACE) inhibitor medication within a time interval of five times the terminal half-life of the ACE inhibitor before study start and during the study
- History of allergic reactions to anticoagulation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, 01307
Nephrocare Rostock GmbH
Rostock, Mecklenburg-Vorpommern, 18059
About this study
Official title: Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI: Cross-over Study in Patients With Cardiovascular Disease and Severe Dyslipidemia
The clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.
Read the detailed description
Comparison of the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.
The primary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis systems MONET and DIAMED with regard to their efficacies in removing total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides and lipoprotein (a) (Lp(a)).
The secondary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis system MONET and DIAMED with regard to their efficacies in removing other novel efficacy parameters.
- Being tested
- Lipoprotein Apheresis MONET and DALI, Lipoprotein Apheresis DIAMED and DALI
- Keywords
- Lipoprotein apheresis
- Medical subject headings
- Hyperlipoproteinemia Type II, Dyslipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoprotein Apheresis MONET and DALIDevice
Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
Lipoprotein Apheresis DIAMED and DALIDevice
Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI
| Study group | Role | What they receive |
|---|---|---|
| Lipoprotein Apheresis MONET and DALI | Other | Patients routinely treated with MONET:
* The first subgroup will be treated first with the MONET adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber System.
* The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the MONET adsorber system Receives: Device: Lipoprotein Apheresis MONET and DALI |
| Lipoprotein Apheresis DIAMED and DALI | Other | Patients routinely treated with DIAMED:
* The first subgroup will be treated first with the DIAMED adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber system.
* The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DIAMED adsorber System. Receives: Device: Lipoprotein Apheresis DIAMED and DALI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal rate of total cholesterol
Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Measured: every week for 6 weeks or biweekly for 12 weeks
Removal rate of low density lipoprotein cholesterol (LDL-C)
Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Measured: every week for 6 weeks or biweekly for 12 weeks
Removal rate of triglycerides
Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Measured: every week for 6 weeks or biweekly for 12 weeks
Removal rate of lipoprotein (a) (Lp(a)).
Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Measured: every week for 6 weeks or biweekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start28 Dec 2018
- Primary completion25 May 2021
- Study completion25 May 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multicentric, open, interventional, cross-over with randomization
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heinrich Prophet, Dr. med., Principal investigator, Nephrocare Rostock GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795038
- Sponsor's protocol ID
- TA-DMD-01-D
- Acronym
- DIAMOND-2018
- Status last verified
- Jul 2022
- First submitted
- 3 Jan 2019
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI: Cross-over Study in Patients With Cardiovascular Disease and Severe Dyslipidemia
- ClinicalTrials.gov ID
- NCT03795038
- Acronym / sponsor ID
- DIAMOND-2018 / TA-DMD-01-D
- Keywords
- Lipoprotein apheresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 7 Jan 2019 (actual)
- 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 clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.
Detailed description
Comparison of the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.
The primary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis systems MONET and DIAMED with regard to their efficacies in removing total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides and lipoprotein (a) (Lp(a)).
The secondary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis system MONET and DIAMED with regard to their efficacies in removing other novel efficacy parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentric, open, interventional, cross-over with randomization
| Arm | Type | Receives |
|---|---|---|
| Lipoprotein Apheresis MONET and DALI | Other | Device: Lipoprotein Apheresis MONET and DALIPatients routinely treated with MONET: * The first subgroup will be treated first with the MONET adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber System. * The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the MONET adsorber system |
| Lipoprotein Apheresis DIAMED and DALI | Other | Device: Lipoprotein Apheresis DIAMED and DALIPatients routinely treated with DIAMED: * The first subgroup will be treated first with the DIAMED adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber system. * The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DIAMED adsorber System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed consent signed and dated by study patient and investigator/authorised physician
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study
- Patients with indication for lipoprotein apheresis confirmed by a local apheresis expert commission according to the German guidelines [1] and with routine lipoprotein apheresis treatments for at least 3 months. Patients with weekly treatments have not missed more than 3 treatment sessions within the 3 months prior inclusion to the study. Patients with biweekly treatment sessions have not missed more than 1 treatment session within the 3 months prior inclusion to the study
- Patients with regular weekly or biweekly lipoprotein apheresis treatments with either MONET or DIAMED lipoprotein apheresis systems for at least 4 weeks (weekly treatments) or 8 weeks (biweekly treatments) with the same system
Key exclusion criteria (10 listed)
- Any condition which could interfere with the patient's ability to comply with the study
- Pregnancy or lactation period (pregnancy test will be conducted with female patients aged 55 years)
- Participation in an interventional clinical study during the preceding 30 days or in the same study
- Occurrence or clinical relevant deterioration of acute myocardial infarction, unstable angina pectoris, severe hemo-dynamic relevant arrhythmia within 3 months prior inclusion to the study
- Bypass surgery, vascular diseases, active infection (this means chronic infectious diseases (e.g. chronic hepatitis) and acute infections with a core body temperature ≥ 38.0 °C) or unstable circulation (see exclusion criteria no. 7) within the last 3 months
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 |
|---|---|---|
| Lipoprotein Apheresis MONET and DALIThree apheresis treatments assigned to one type of apheresis system of MONETand DALI | Device | Lipoprotein Apheresis MONET and DALI |
| Lipoprotein Apheresis DIAMED and DALIThree apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI | Device | Lipoprotein Apheresis DIAMED and DALI |
Primary outcome
Removal rate of total cholesterol
Time frame: every week for 6 weeks or biweekly for 12 weeks
Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Removal rate of low density lipoprotein cholesterol (LDL-C)
Time frame: every week for 6 weeks or biweekly for 12 weeks
Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Removal rate of triglycerides
Time frame: every week for 6 weeks or biweekly for 12 weeks
Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Removal rate of lipoprotein (a) (Lp(a)).
Time frame: every week for 6 weeks or biweekly for 12 weeks
Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
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 28 Jul 2022.
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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.
Heinrich Prophet, Dr. med. principal investigator
Nephrocare Rostock GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipoprotein Apheresis MONET and DALI and Lipoprotein Apheresis DIAMED and DALI in people with Hypercholesterolemia, Familial and Dyslipidemias, run by Fresenius Medical Care Deutschland GmbH at 2 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 10 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 28 Jul 2022. 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 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?
Removal rate of total cholesterol (time frame: every week for 6 weeks or biweekly for 12 weeks). The study lists 4 primary outcomes in all. 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 28 Jul 2022.