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

Completed

• Conditions: Hypercholesterolemia, Familial; LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
• Interventions: Device: DALI-adsorber; Device: MONET-Lipoprotein filter

• Registration Number: NCT01753232
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief 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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Primary Completion: 2014-12
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DALI-adsorber, hypercholesterolemia	DALI-adsorber	Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system
MONET-Filter, hypercholesterolemia	MONET-Lipoprotein filter	Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Only in patients with isolated Lp(a) increase
Change of High Density Lipoprotein (HDL)-concentration	Every two weeks to every three months for 24 months	Only for treatment sessions with lab results
Change of triglyceride-concentration	Every two weeks to every three months for 24 months	Only for treatment sessions with lab results
Change in blood count	Every two weeks to every three months for 24 months	Only for treatment sessions with lab results
Change of blood pressure and heart rate	Every two weeks to every three months for 24 months	Only for treatment sessions with lab results
Blood or plasma flow	Every two weeks to every three months for 24 months
Change of total cholesterol	Every two weeks to every three months for 24 months	Only for treatment sessions with lab results
Change of creatinine-concentration	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
Change of fibrinogen-concentration	Every two weeks to every three months for 24 months	Only for treatment sessions with lab results
Change of Immunoglobulins (Ig)	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.
Change in C Reactive Protein (CRP)-concentration	Every two weeks to every three months for 24 months	Only for treatment sessions with lab results

Trial Locations

Locations (11)

Nierenzentrum Mannheim; 🇩🇪 Mannheim, Baden Würtemberg, Germany

Medizinisches Versorgungszentrum; 🇩🇪 Kempten, Bayern, Germany

Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin; 🇩🇪 Regensburg, Bayern, Germany

Dialysezentrum Potsdam; 🇩🇪 Potsdam, Brandenburg, Germany

Apheresezentrum Rostock; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany

Nephrologisches Zentrum Goettingen; 🇩🇪 Goettingen, Niedersachsen, Germany

Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum; 🇩🇪 Essen, Nordrhein Westfalen, Germany

Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering; 🇩🇪 Hannover, Niedersachsen, Germany

Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Apheresezentrum Ingelheim; 🇩🇪 Ingelheim, Rheinland Pfalz, Germany

Dialysezentrum Magdeburg-Stattfeld; 🇩🇪 Magdeburg, Sachsen Anhalt, Germany