Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI
DIAMOND-2018
1 other identifier
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 28, 2018
CompletedFirst Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2021
CompletedJuly 28, 2022
July 1, 2022
2.4 years
January 3, 2019
July 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
every week for 6 weeks or biweekly for 12 weeks
Study Arms (2)
Lipoprotein Apheresis MONET and DALI
OTHERPatients 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
OTHERPatients 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.
Interventions
Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI
Eligibility Criteria
You may qualify if:
- 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 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
- With adequate venous access
- With systolic blood pressure \> 100 mmHg
- With stable hematocrit \>35 %
- With stable anticoagulation
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nephrocare Rostock GmbH
Rostock, Mecklenburg-Vorpommern, 18059, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, 01307, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heinrich Prophet, Dr. med.
Nephrocare Rostock GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2019
First Posted
January 7, 2019
Study Start
December 28, 2018
Primary Completion
May 25, 2021
Study Completion
May 25, 2021
Last Updated
July 28, 2022
Record last verified: 2022-07