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

Primary Purpose

Hypercholesterolemia, Familial, Dyslipidemias, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lipoprotein Apheresis MONET and DALI
Lipoprotein Apheresis DIAMED and DALI
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia, Familial focused on measuring Lipoprotein apheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nephrocare Rostock GmbH
  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Lipoprotein Apheresis MONET and DALI

Lipoprotein Apheresis DIAMED and DALI

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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
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
Removal rate of triglycerides
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)).
Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems

Secondary Outcome Measures

Full Information

First Posted
January 3, 2019
Last Updated
July 27, 2022
Sponsor
Fresenius Medical Care Deutschland GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03795038
Brief Title
Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI
Acronym
DIAMOND-2018
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 28, 2018 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Familial, Dyslipidemias, Cardiovascular Diseases
Keywords
Lipoprotein apheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, multicentric, open, interventional, cross-over with randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lipoprotein Apheresis MONET and DALI
Arm Type
Other
Arm Description
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
Arm Title
Lipoprotein Apheresis DIAMED and DALI
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lipoprotein Apheresis MONET and DALI
Intervention Description
Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
Intervention Type
Device
Intervention Name(s)
Lipoprotein Apheresis DIAMED and DALI
Intervention Description
Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI
Primary Outcome Measure Information:
Title
Removal rate of total cholesterol
Description
Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time Frame
every week for 6 weeks or biweekly for 12 weeks
Title
Removal rate of low density lipoprotein cholesterol (LDL-C)
Description
Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time Frame
every week for 6 weeks or biweekly for 12 weeks
Title
Removal rate of triglycerides
Description
Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time Frame
every week for 6 weeks or biweekly for 12 weeks
Title
Removal rate of lipoprotein (a) (Lp(a)).
Description
Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time Frame
every week for 6 weeks or biweekly for 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinrich Prophet, Dr. med.
Organizational Affiliation
Nephrocare Rostock GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrocare Rostock GmbH
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18059
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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

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