Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795038
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia, Familial Dyslipidemias Cardiovascular Diseases Device: Lipoprotein Apheresis MONET and DALI Device: Lipoprotein Apheresis DIAMED and DALI Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective, monocentric, open, interventional, cross-over with randomization
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 and with routine apheresis treatments for at least 3 months
  • 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
  • Bypass surgery, vascular diseases, active infection, unstable circulation 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795038


Contacts
Layout table for location contacts
Contact: Manuela Stauss-Grabo, Dr +49 6172 609 5248 Manuela.Stauss-Grabo@fmc-ag.com
Contact: Mareike Giefer Mareike.Giefer@fmc-ag.com

Locations
Layout table for location information
Germany
Nephrocare Rostock GmbH Recruiting
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Contact: Wolfgang Ramlow, Dr. med.         
Principal Investigator: Wolfgang Ramlow, Dr. med.         
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
Layout table for investigator information
Principal Investigator: Wolfgang Ramlow, Dr. med. Nephrocare Rostock GmbH

Layout table for additonal information
Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT03795038     History of Changes
Other Study ID Numbers: TA-DMD-01-D
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fresenius Medical Care Deutschland GmbH:
Lipoprotein apheresis
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperlipoproteinemia Type II
Hypercholesterolemia
Dyslipidemias
Cardiovascular Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias