Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI (DIAMOND-2018)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Dyslipidemias; Hypercholesterolemia, Familial
• Intervention / Treatment: Device: Lipoprotein Apheresis MONET and DALI; Device: Lipoprotein Apheresis DIAMED and DALI

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18059
      • Nephrocare Rostock GmbH
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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
• 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

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: Lipoprotein Apheresis MONET and DALI; Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
Other: 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.	Device: Lipoprotein Apheresis DIAMED and DALI; Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Investigators: Principal Investigator: Heinrich Prophet, Dr. med., Nephrocare Rostock GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2018
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Lipoprotein apheresis
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Cardiovascular Diseases; Dyslipidemias; Hypercholesterolemia; Hyperlipoproteinemia Type II
• Other Study ID Numbers: TA-DMD-01-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No