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

This study is currently recruiting participants.
Verified December 2012 by Fresenius Medical Care Deutschland GmbH
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT01753232
First received: December 13, 2012
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Adsorptin 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 Intervention
Hypercholesterolemia, Familial
LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
 Device: DALI-adsorber
Device: MONET-Lipoprotein filter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Fresenius Medical Care Deutschland GmbH:

Primary Outcome Measures:
  • Change of Low Density Lipoprotein (LDL)-Concentration [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
    Data are only recorded for visits with lab results


Secondary Outcome Measures:
  • Blood/plasma volume treated [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
  • Number of occurence of adverse and serious adverse device effects [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Change of Lipoprotein(a)-concentration [ Time Frame: Pre/post treatment over 24 months, once per month or every 3 months ] [ Designated as safety issue: No ]
    Only in patients with isolated Lp(a) inrease

  • Change of total cholesterol [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
    Only for treatment sessions with lab results

  • Change of High Density Lipoprotein (HDL)-concentration [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
    Only for treatment sessions with lab results

  • Change of triglyceride-concentration [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
    Only for treatment sessions with lab results

  • Change in blood count [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: Yes ]
    Only for treatment sessions with lab results

  • Change of fibrinogen-concentration [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: Yes ]
    Only for treatment sessions with lab results

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

  • Change in C Reactive Protein (CRP)-concentration [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: Yes ]
    Only for treatment sessions with lab results

  • Change of blood pressure and heart rate [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: Yes ]
    Only for treatment sessions with lab results

  • Blood or plasma flow [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
  • Anticoagulation regime [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
  • Treatment time [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]
  • Medication [ Time Frame: Every two weeks to every three months for 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753232

Contacts
Contact: Ingrid Uhlenbusch-Koerwer, PhD +49 6172 609 ext 4047 ingrid.uhlenbusch-koerwer@fmc-ag.com

Locations
Germany
Nierenzentrum Mannheim Completed
Mannheim, Baden Würtemberg, Germany, 68309
Medizinisches Versorgungszentrum Completed
Kempten, Bayern, Germany, 87439
Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin Completed
Regensburg, Bayern, Germany, 93053
Dialysezentrum Potsdam Completed
Potsdam, Brandenburg, Germany, 14482
Apheresezentrum Rostock Completed
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Nephrologisches Zentrum Goettingen Recruiting
Goettingen, Niedersachsen, Germany, 37075
Principal Investigator: Volker Schettler, MD            
Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering Completed
Hannover, Niedersachsen, Germany, 30625
Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum Completed
Essen, Nordrhein Westfalen, Germany, 45127
Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann Completed
Köln, Nordrhein-Westfalen, Germany, 51105
Apheresezentrum Ingelheim Recruiting
Ingelheim, Rheinland Pfalz, Germany, 55218
Principal Investigator: Frido Himmelsbach, MD            
Dialysezentrum Magdeburg-Stattfeld Completed
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
  More Information

No publications provided

Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01753232     History of Changes
Other Study ID Numbers: TA-DALI-MONET-01-D
Study First Received: December 13, 2012
Last Updated: December 17, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 22, 2013