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

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.

Conditions

• Hypercholesterolemia, Familial
• LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA

Interventions

DEVICE

DALI-adsorber

Recording of treatment data. No extra interventional treatment

DEVICE

MONET-Lipoprotein filter

Only treatment data recording. No extra interventional treatment

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH

  lead INDUSTRY

Principal Investigators

• Rainer Heinzler, MD · Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann

• Franz Heigl, MD · Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum

• Frank Leistikow, MD · Nierenzentrum Mannheim

• Frido Himmelsbach, MD · Apheresezentrum Ingelheim

• Ralf Spitthöver, MD · Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum

• Eberhard Roeseler, MD, Prof · Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort Heidering

• Volker Schettler, MD · Nephrologisches Zentrum Goettingen

• Gerd Schmitz, MD, Prof · University Regensburg Department Clinical Chemistry and Laboratory Medicine

• Nadim Abduhl-Rahman, MD · Dialysezentrum Magdeburg-Stadtfeld

• Jens Ringel, MD · Dialysezentrum Potsdam

• Wolfgang Ramlow, MD · Apheresezentrum Rostock

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2014-12-31

Completion

2015-08-31

Countries

• Germany

Study Locations