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Completed

NCT Number: NCT01753232

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

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.

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Key information

Conditions

Hypercholesterolemia, Familial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nierenzentrum Mannheim, Mannheim, Baden Würtemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DALI-adsorber

Device

Recording of treatment data. No extra interventional treatment

MONET-Lipoprotein filter

Device

Only treatment data recording. No extra interventional treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter

Acronym: LINET

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 20, 2012
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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