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

Hypercholesterolemia, Familial Clinical Trial

— LINET  

Official title:

Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753232
• Other study ID #: TA-DALI-MONET-01-D
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: September 3, 2015
• Start date: May 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipoproteinemia Type II
• Hyperlipoproteinemias
• LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA

Intervention

Device:
• DALI-adsorber
Recording of treatment data. No extra interventional treatment
• MONET-Lipoprotein filter
Only treatment data recording. No extra interventional treatment

Locations

Country	Name	City	State
Germany	Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum	Essen	Nordrhein Westfalen
Germany	Nephrologisches Zentrum Goettingen	Goettingen	Niedersachsen
Germany	Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering	Hannover	Niedersachsen
Germany	Apheresezentrum Ingelheim	Ingelheim	Rheinland Pfalz
Germany	Medizinisches Versorgungszentrum	Kempten	Bayern
Germany	Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann	Köln	Nordrhein-Westfalen
Germany	Dialysezentrum Magdeburg-Stattfeld	Magdeburg	Sachsen Anhalt
Germany	Nierenzentrum Mannheim	Mannheim	Baden Würtemberg
Germany	Dialysezentrum Potsdam	Potsdam	Brandenburg
Germany	Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin	Regensburg	Bayern
Germany	Apheresezentrum Rostock	Rostock	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood/plasma volume treated		Every two weeks to every three months for 24 months	No
Secondary	Number of occurence of adverse and serious adverse device effects		24 months	Yes
Secondary	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	No
Secondary	Change of total cholesterol	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months	No
Secondary	Change of High Density Lipoprotein (HDL)-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months	No
Secondary	Change of triglyceride-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months	No
Secondary	Change in blood count	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months	Yes
Secondary	Change of fibrinogen-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months	Yes
Secondary	Change of creatinine-concentration		Every two weeks to every three months for 24 months	Yes
Secondary	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	Yes
Secondary	Change in C Reactive Protein (CRP)-concentration	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months	Yes
Secondary	Change of blood pressure and heart rate	Only for treatment sessions with lab results	Every two weeks to every three months for 24 months	Yes
Secondary	Blood or plasma flow		Every two weeks to every three months for 24 months	No
Secondary	Anticoagulation regime		Every two weeks to every three months for 24 months	No
Secondary	Treatment time		Every two weeks to every three months for 24 months	No
Secondary	Medication		Every two weeks to every three months for 24 months	No