Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI

NCT ID: NCT03795038

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2021-05-25

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.

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.

Conditions

Hypercholesterolemia, Familial; Dyslipidemias; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipoprotein Apheresis MONET and DALI

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

Group Type: OTHER

Lipoprotein Apheresis MONET and DALI

Intervention Type: DEVICE

Three apheresis treatments assigned to one type of apheresis system of MONETand DALI

Lipoprotein Apheresis DIAMED and DALI

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.

Group Type: OTHER

Lipoprotein Apheresis DIAMED and DALI

Intervention Type: DEVICE

Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI

Interventions

Lipoprotein Apheresis MONET and DALI

Three apheresis treatments assigned to one type of apheresis system of MONETand DALI

Intervention Type: DEVICE

Lipoprotein Apheresis DIAMED and DALI

Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• With adequate venous access
• With systolic blood pressure > 100 mmHg
• With stable hematocrit >35 %
• With stable anticoagulation

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heinrich Prophet, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Nephrocare Rostock GmbH

Locations

Nephrocare Rostock GmbH

Rostock, Mecklenburg-Vorpommern, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, Germany

Countries

Germany

Other Identifiers

TA-DMD-01-D

Identifier Type: -

Identifier Source: org_study_id