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(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol (FUTURA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Medical Inc.
ClinicalTrials.gov Identifier:
NCT00526058
First received: September 5, 2007
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute reduction of LDL-cholesterol from the plasma in populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated.


Condition Intervention
Hypercholesterolemia
Device: Secura Device: Futura
Device: Futura Device: Secura

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized Multicenter Crossover Study to Compare the Plasmat® Futura Heparin Induced Extracorporeal Lower Density Lipo-Protein (LDL) Precipitation (H.E.L.P.) Apheresis System to the Approved Secura System in the Reduction of LDL-c in Patients With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by B. Braun Medical Inc.:

Primary Outcome Measures:
  • Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System. [ Time Frame: Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24.. ] [ Designated as safety issue: No ]
  • Percent Change of the Pre and Post Treatment Value [ Time Frame: Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24. ] [ Designated as safety issue: No ]
    The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.


Secondary Outcome Measures:
  • Clinical Lab Profiles [ Time Frame: Analyzed at specific time points throughout the study from week 0 to week 24. ] [ Designated as safety issue: No ]
    Blood samples will be obtained for hematology; coagulation, Prothrombin time, , and Inflammatory markers,chemistry (Alkaline phosphatase, blood urea nitrogen, CPK (Creatine phosphokinase, Creatinine, Ferritin, Glucose, Lactate dehydrogenase, Phosphate, and uric acid) and liver functions (Total Protein, Total bilirubin, Alanine Aminotransferase (ALT), Aspartate transaminase (AST); immunoglobulins; complement components; endocrine; and urinalysis (color, specific gravity, wbc (white blood count), rbc (red blood count), urinary dipstick chemistry, and examination of sediment) will be obtained.

  • Device Parameters [ Time Frame: Analyzed at specific time points throughout the study from week 0 to week 24. ] [ Designated as safety issue: No ]

    Apheresis Machine Physical parameters; Parameter Description (Abbreviation) Plasmat® Secura Plasma Flow (Plasma Pump) Plasma Pressure 1 (PLP 1) Plasma Pressure 2 (PLP 2) Filtration Pressure 1 (FP 1) Transmembrane Pressure (TMP) Plasmat® Futura Plasma Flow (Plasma Pump) Pressure at Precipitate Filter (PPF) Pressure at Dialysis Filter (PDF) Pressure Drop Across Precipitate Adsorber (PDPA)*

    • PDPA = PPF - PDF


Enrollment: 18
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
The Group Randomized first to the approved Plasmat® Secura apheresis system and then to the Plasmat® Futura apheresis system.
Device: Secura Device: Futura
Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.
B
The Group Randomized first to the approved Plasmat® Futura apheresis system and then to the Plasmat® Secura apheresis system.
Device: Futura Device: Secura
Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.

Detailed Description:

The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements between the approved H.E.L.P. system and the modified H.E.L.P. system. The secondary study endpoints are clinical lab profiles and device parameters analyzed at specific time points throughout the study.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is between 25 and 70 years of age (inclusive) at the time of randomization.
  • Subject is an appropriate candidate for H.E.L.P. apheresis treatment for hypercholesterolemia according to current Plasmat® Secura approval criteria.
  • Subject has received a minimum of two consecutive bi-monthly* H.E.L.P. apheresis treatments using the Plasmat® Secura apheresis system >30 days prior to the screening visit.
  • Subject is willing to maintain cholesterol lowering dietary and drug therapies as prescribed through the course of the study.
  • Subject is willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Waiver.
  • Sterile, post-menopausal, or using acceptable birth control for the duration of the study. Acceptable birth control is defined as having a vasectomized, postmenopausal, or sterile partner; the ongoing use of approved hormonal contraceptives, barrier method, or an intrauterine device; or abstinence.

    • Every 14 days (±2 days)

Exclusion Criteria:

  • A History of a known sensitivity to heparin or ethylene oxide.
  • A history of hemorrhagic diathesis, bleeding/clotting disorder, thrombocytopenia (defined as platelet count < 150 x109/L), or for whom the use of heparin would cause excessive or uncontrolled anticoagulation or for whom adequate anticoagulation cannot be safely achieved (ie., hemophilia, recent surgery, acute internal bleeding, gastrointestinal ulcers).
  • Females who are pregnant or lactating.
  • Subjects< 106 lbs. or <48.2 kg in body weight; or whose weight is >1.5 times their ideal weight.
  • Certain cardiac impairments such as congestive heart failure, major arrhythmia, or diastolic blood pressure greater than 100 mm/Hg on two separate occasions at least 24 hours apart.
  • Renal insufficiency defined as creatinine greater >2.0 mg/dlL or is dependent upon renal dialysis.
  • Untreated hypothyroidism; uncontrolled diabetes mellitus; or fasting triglycerides >500 mg/dL.
  • Serious systemic disease (e.g., advanced neoplasms, and acute hepatitis) including Immune system suppression or compromise, that could preclude survival to study completion.
  • History of stroke within 6 months of the screening visit.
  • Received thrombolytic treatment < 7 days of screening.visit.
  • Taken or requires a prohibited treatment < 30 days prior to the Screening Visit, or requires a prohibited treatment at anytime during the course of the study.
  • Neutropenia (neutrophil count < 0.5 x109/L).
  • History of liver disease or serum ALT and/or AST > 2X upper limit of normal range.
  • History of dementia.
  • History of anemia (value outside the lower normal range).
  • acetyl salicylic acid (ASA) > 325 mg/day.
  • Subject currently enrolled in another investigational study (does not apply to PMS for Secura device).
  • Subject with any other medical condition that in the opinion of the investigator might put the subject at risk or interfere with his/her participation.
  • Subject is unwilling or unable to comply with the protocol or to cooperate fully with the investigator or site personnel.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526058

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
B. Braun Medical Inc.
Investigators
Principal Investigator: Patrick Moriarty, M.D. University of Kansas
Principal Investigator: Paul Thompson, M.D. Hartford Hospital
  More Information

Publications:
Responsible Party: B. Braun Medical Inc.
ClinicalTrials.gov Identifier: NCT00526058     History of Changes
Other Study ID Numbers: LDLc-A-US2-0406
Study First Received: September 5, 2007
Results First Received: May 25, 2010
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by B. Braun Medical Inc.:
Heparin
Extracorporeal
Low Density Lipo-Protein (LDL) Cholesterol
Apheresis
Device

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Miconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014