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

September 3, 2015 updated by: Fresenius Medical Care Deutschland GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden Würtemberg
      • Mannheim, Baden Würtemberg, Germany, 68309
        • Nierenzentrum Mannheim
    • Bayern
      • Kempten, Bayern, Germany, 87439
        • Medizinisches Versorgungszentrum
      • Regensburg, Bayern, Germany, 93053
        • Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14482
        • Dialysezentrum Potsdam
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • Apheresezentrum Rostock
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Nephrologisches Zentrum Goettingen
      • Hannover, Niedersachsen, Germany, 30625
        • Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering
    • Nordrhein Westfalen
      • Essen, Nordrhein Westfalen, Germany, 45127
        • Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51105
        • Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
    • Rheinland Pfalz
      • Ingelheim, Rheinland Pfalz, Germany, 55218
        • Apheresezentrum Ingelheim
    • Sachsen Anhalt
      • Magdeburg, Sachsen Anhalt, Germany, 39108
        • Dialysezentrum Magdeburg-Stattfeld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
DALI-adsorber, hypercholesterolemia
Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system
Device: DALI-adsorber
Recording of treatment data. No extra interventional treatment
MONET-Filter, hypercholesterolemia
Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter
Device: MONET-Lipoprotein filter
Only treatment data recording. No extra interventional treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Low Density Lipoprotein (LDL)-Concentration
Time Frame: Every two weeks to every three months for 24 months
Data are only recorded for visits with lab results
Every two weeks to every three months for 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood/plasma volume treated
Time Frame: Every two weeks to every three months for 24 months
Every two weeks to every three months for 24 months
Number of occurence of adverse and serious adverse device effects
Time Frame: 24 months
24 months
Change of Lipoprotein(a)-concentration
Time Frame: Pre/post treatment over 24 months, once per month or every 3 months
Only in patients with isolated Lp(a) increase
Pre/post treatment over 24 months, once per month or every 3 months
Change of total cholesterol
Time Frame: Every two weeks to every three months for 24 months
Only for treatment sessions with lab results
Every two weeks to every three months for 24 months
Change of High Density Lipoprotein (HDL)-concentration
Time Frame: Every two weeks to every three months for 24 months
Only for treatment sessions with lab results
Every two weeks to every three months for 24 months
Change of triglyceride-concentration
Time Frame: Every two weeks to every three months for 24 months
Only for treatment sessions with lab results
Every two weeks to every three months for 24 months
Change in blood count
Time Frame: Every two weeks to every three months for 24 months
Only for treatment sessions with lab results
Every two weeks to every three months for 24 months
Change of fibrinogen-concentration
Time Frame: Every two weeks to every three months for 24 months
Only for treatment sessions with lab results
Every two weeks to every three months for 24 months
Change of creatinine-concentration
Time Frame: Every two weeks to every three months for 24 months
Every two weeks to every three months for 24 months
Change of Immunoglobulins (Ig)
Time Frame: 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.
Every two weeks to every three months for 24 months
Change in C Reactive Protein (CRP)-concentration
Time Frame: Every two weeks to every three months for 24 months
Only for treatment sessions with lab results
Every two weeks to every three months for 24 months
Change of blood pressure and heart rate
Time Frame: Every two weeks to every three months for 24 months
Only for treatment sessions with lab results
Every two weeks to every three months for 24 months
Blood or plasma flow
Time Frame: Every two weeks to every three months for 24 months
Every two weeks to every three months for 24 months
Anticoagulation regime
Time Frame: Every two weeks to every three months for 24 months
Every two weeks to every three months for 24 months
Treatment time
Time Frame: Every two weeks to every three months for 24 months
Every two weeks to every three months for 24 months
Medication
Time Frame: Every two weeks to every three months for 24 months
Every two weeks to every three months for 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Medical Care Deutschland GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TA-DALI-MONET-01-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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