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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01753232
Other study ID # TA-DALI-MONET-01-D
Secondary ID
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


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
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