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Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter (LINET)

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ClinicalTrials.gov Identifier: NCT01753232
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

Brief Summary:
Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.

Condition or disease Intervention/treatment
Hypercholesterolemia, Familial LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA Device: DALI-adsorber Device: MONET-Lipoprotein filter

Detailed Description:
Data were recorded from patients suffering from familial hypercholesterolemia and treated by lipid apheresis using one of the two systems investigated for at least 3 months prior to inclusion in the study. Only those treatments were documented in which routine blood samples for laboratory analysis were taken, or in which adverse or serious adverse device effects occur.

Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter
Study Start Date : May 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
DALI-adsorber, hypercholesterolemia
Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system
Device: DALI-adsorber
Recording of treatment data. No extra interventional treatment
MONET-Filter, hypercholesterolemia
Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter
Device: MONET-Lipoprotein filter
Only treatment data recording. No extra interventional treatment



Primary Outcome Measures :
  1. Change of Low Density Lipoprotein (LDL)-Concentration [ Time Frame: Every two weeks to every three months for 24 months ]
    Data are only recorded for visits with lab results


Secondary Outcome Measures :
  1. Blood/plasma volume treated [ Time Frame: Every two weeks to every three months for 24 months ]
  2. Number of occurence of adverse and serious adverse device effects [ Time Frame: 24 months ]
  3. Change of Lipoprotein(a)-concentration [ Time Frame: Pre/post treatment over 24 months, once per month or every 3 months ]
    Only in patients with isolated Lp(a) increase

  4. Change of total cholesterol [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results

  5. Change of High Density Lipoprotein (HDL)-concentration [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results

  6. Change of triglyceride-concentration [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results

  7. Change in blood count [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results

  8. Change of fibrinogen-concentration [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results

  9. Change of creatinine-concentration [ Time Frame: Every two weeks to every three months for 24 months ]
  10. Change of Immunoglobulins (Ig) [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results, Immunoglobulin (Ig) G, IgA and IgM if measured. In MONET patients only.

  11. Change in C Reactive Protein (CRP)-concentration [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results

  12. Change of blood pressure and heart rate [ Time Frame: Every two weeks to every three months for 24 months ]
    Only for treatment sessions with lab results

  13. Blood or plasma flow [ Time Frame: Every two weeks to every three months for 24 months ]
  14. Anticoagulation regime [ Time Frame: Every two weeks to every three months for 24 months ]
  15. Treatment time [ Time Frame: Every two weeks to every three months for 24 months ]
  16. Medication [ Time Frame: Every two weeks to every three months for 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department
Criteria

Inclusion Criteria:

  • given informed consent
  • 18 years or older
  • patient compliant to therapy as prescribed
  • at least two therapy sessions per month
  • treatment with DALI or MONET system for at least 3 months before inclusion
  • last severe invasive intervention in hospital more than 3 months ago

Exclusion Criteria:

  • earlier participation in the study
  • unconscious patient/persons without capacity to contract
  • for DALI: intake of ACE-inhibitors

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): NCT01753232


Locations
Germany
Nierenzentrum Mannheim
Mannheim, Baden Würtemberg, Germany, 68309
Medizinisches Versorgungszentrum
Kempten, Bayern, Germany, 87439
Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin
Regensburg, Bayern, Germany, 93053
Dialysezentrum Potsdam
Potsdam, Brandenburg, Germany, 14482
Apheresezentrum Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Nephrologisches Zentrum Goettingen
Goettingen, Niedersachsen, Germany, 37075
Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering
Hannover, Niedersachsen, Germany, 30625
Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
Essen, Nordrhein Westfalen, Germany, 45127
Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
Köln, Nordrhein-Westfalen, Germany, 51105
Apheresezentrum Ingelheim
Ingelheim, Rheinland Pfalz, Germany, 55218
Dialysezentrum Magdeburg-Stattfeld
Magdeburg, Sachsen Anhalt, Germany, 39108
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
Principal Investigator: Rainer Heinzler, MD Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
Principal Investigator: Franz Heigl, MD Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum
Principal Investigator: Frank Leistikow, MD Nierenzentrum Mannheim
Principal Investigator: Frido Himmelsbach, MD Apheresezentrum Ingelheim
Principal Investigator: Ralf Spitthöver, MD Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
Principal Investigator: Eberhard Roeseler, MD, Prof Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort Heidering
Principal Investigator: Volker Schettler, MD Nephrologisches Zentrum Goettingen
Principal Investigator: Gerd Schmitz, MD, Prof University Regensburg Department Clinical Chemistry and Laboratory Medicine
Principal Investigator: Nadim Abduhl-Rahman, MD Dialysezentrum Magdeburg-Stadtfeld
Principal Investigator: Jens Ringel, MD Dialysezentrum Potsdam
Principal Investigator: Wolfgang Ramlow, MD Apheresezentrum Rostock

Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01753232     History of Changes
Other Study ID Numbers: TA-DALI-MONET-01-D
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Keywords provided by Fresenius Medical Care Deutschland GmbH:
DALI adsorber
MONET lipoprotein filter

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemias
Hyperlipidemias
Hyperlipoproteinemia Type II
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn