NCT01753232|Completed
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
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LINET
Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter
Sponsor study identifier
observational
108
1 country
11
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 13, 2012
Actual (reported)December 20, 2012
Actual (reported)December 2014
Actual (reported)August 2015
Actual (reported)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
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
Pre/post treatment over 24 months, once per month or every 3 months
Change of total cholesterol
Every two weeks to every three months for 24 months
Change of High Density Lipoprotein (HDL)-concentration
Every two weeks to every three months for 24 months
Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system
Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter
Recording of treatment data. No extra interventional treatment
Only treatment data recording. No extra interventional treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department
Nierenzentrum Mannheim
Mannheim, Baden Würtemberg, 68309, Germany
Medizinisches Versorgungszentrum
Kempten (Allgäu), Bavaria, 87439, Germany
Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin
Regensburg, Bavaria, 93053, Germany
Dialysezentrum Potsdam
Potsdam, Brandenburg, 14482, Germany
Nephrologisches Zentrum Goettingen
Göttingen, Lower Saxony, 37075, Germany
Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering
Hanover, Lower Saxony, 30625, Germany
Apheresezentrum Rostock
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
108 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2012
First Posted
December 20, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels in Familial Hypercholesterolemia
Contact the study team to confirm eligibility.
Rostock, Mecklenburg-Vorpommern, 18059, Germany
Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
Cologne, North Rhine-Westphalia, 51105, Germany
Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
Essen, North Rhine-Westphalia, 45127, Germany
Apheresezentrum Ingelheim
Ingelheim, Rhineland-Palatinate, 55218, Germany
Dialysezentrum Magdeburg-Stattfeld
Magdeburg, Saxony-Anhalt, 39108, Germany
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
Primary Completion
December 2014
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
September 4, 2015
Record last verified: 2015-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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