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

Non-interventional Study: 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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia, Familial; LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
• Intervention / Treatment: 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
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Germany
  • Baden Würtemberg
    • Mannheim, Baden Würtemberg, Germany, 68309
      • Nierenzentrum Mannheim
  • Bayern
    • Kempten, Bayern, Germany, 87439
      • Medizinisches Versorgungszentrum
    • Regensburg, Bayern, Germany, 93053
      • Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14482
      • Dialysezentrum Potsdam
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18059
      • Apheresezentrum Rostock
  • Niedersachsen
    • Goettingen, Niedersachsen, Germany, 37075
      • Nephrologisches Zentrum Goettingen
    • Hannover, Niedersachsen, Germany, 30625
      • Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering
  • Nordrhein Westfalen
    • Essen, Nordrhein Westfalen, Germany, 45127
      • Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 51105
      • Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
  • Rheinland Pfalz
    • Ingelheim, Rheinland Pfalz, Germany, 55218
      • Apheresezentrum Ingelheim
  • Sachsen Anhalt
    • Magdeburg, Sachsen Anhalt, Germany, 39108
      • Dialysezentrum Magdeburg-Stattfeld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Low Density Lipoprotein (LDL)-Concentration	Data are only recorded for visits with lab results	Every two weeks to every three months for 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood/plasma volume treated		Every two weeks to every three months for 24 months
Number of occurence of adverse and serious adverse device effects		24 months
Change of Lipoprotein(a)-concentration	Only in patients with isolated Lp(a) increase	Pre/post treatment over 24 months, once per month or every 3 months
Change of total cholesterol	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months
Change of High Density Lipoprotein (HDL)-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months
Change of triglyceride-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months
Change in blood count	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months
Change of fibrinogen-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months
Change of creatinine-concentration		Every two weeks to every three months for 24 months
Change of Immunoglobulins (Ig)	Only for treatment sessions with lab results, Immunoglobulin (Ig) G, IgA and IgM if measured. In MONET patients only.	Every two weeks to every three months for 24 months
Change in C Reactive Protein (CRP)-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months
Change of blood pressure and heart rate	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months
Blood or plasma flow		Every two weeks to every three months for 24 months
Anticoagulation regime		Every two weeks to every three months for 24 months
Treatment time		Every two weeks to every three months for 24 months
Medication		Every two weeks to every three months for 24 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: DALI adsorber; MONET lipoprotein filter
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemia Type II; Hyperlipoproteinemias
• Other Study ID Numbers: TA-DALI-MONET-01-D