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

NCT01753232 | Completed

• 1 other identifier: TA-DALI-MONET-01-D
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Keywords

DALI adsorber; MONET lipoprotein filter

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• 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

Study Arms (2)

DALI-adsorber, hypercholesterolemia

Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system

Device: DALI-adsorber

MONET-Filter, hypercholesterolemia

Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter

Device: MONET-Lipoprotein filter

Interventions

DALI-adsorber DEVICE

Recording of treatment data. No extra interventional treatment

DALI-adsorber, hypercholesterolemia

MONET-Lipoprotein filter DEVICE

Only treatment data recording. No extra interventional treatment

MONET-Filter, hypercholesterolemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department

You may qualify if:

• given informed consent
• years or older
• patient compliant to therapy as prescribed
• at least two therapy sessions per month
• last severe invasive intervention in hospital more than 3 months ago

You may not qualify if:

• earlier participation in the study
• unconscious patient/persons without capacity to contract
• for DALI: intake of ACE-inhibitors

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (11)

Nierenzentrum Mannheim

Mannheim, Baden Würtemberg, 68309, Germany

Location

Medizinisches Versorgungszentrum

Kempten (Allgäu), Bavaria, 87439, Germany

Location

Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin

Regensburg, Bavaria, 93053, Germany

Location

Dialysezentrum Potsdam

Potsdam, Brandenburg, 14482, Germany

Location

Nephrologisches Zentrum Goettingen

Göttingen, Lower Saxony, 37075, Germany

Location

Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering

Hanover, Lower Saxony, 30625, Germany

Location

Apheresezentrum Rostock

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann

Cologne, North Rhine-Westphalia, 51105, Germany

Location

Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum

Essen, North Rhine-Westphalia, 45127, Germany

Location

Apheresezentrum Ingelheim

Ingelheim, Rhineland-Palatinate, 55218, Germany

Location

Dialysezentrum Magdeburg-Stattfeld

Magdeburg, Saxony-Anhalt, 39108, Germany

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rainer Heinzler, MD

  Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann

  PRINCIPAL INVESTIGATOR

• Franz Heigl, MD

  Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum

  PRINCIPAL INVESTIGATOR

• Frank Leistikow, MD

  Nierenzentrum Mannheim

  PRINCIPAL INVESTIGATOR

• Frido Himmelsbach, MD

  Apheresezentrum Ingelheim

  PRINCIPAL INVESTIGATOR

• Ralf Spitthöver, MD

  Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum

  PRINCIPAL INVESTIGATOR

• Eberhard Roeseler, MD, Prof

  Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort Heidering

  PRINCIPAL INVESTIGATOR

• Volker Schettler, MD

  Nephrologisches Zentrum Goettingen

  PRINCIPAL INVESTIGATOR

• Gerd Schmitz, MD, Prof

  University Regensburg Department Clinical Chemistry and Laboratory Medicine

  PRINCIPAL INVESTIGATOR

• Nadim Abduhl-Rahman, MD

  Dialysezentrum Magdeburg-Stadtfeld

  PRINCIPAL INVESTIGATOR

• Jens Ringel, MD

  Dialysezentrum Potsdam

  PRINCIPAL INVESTIGATOR

• Wolfgang Ramlow, MD

  Apheresezentrum Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 20, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

DE (11)