Status:
UNKNOWN
Study to Evaluate the Safety, Tolerability and Short Term Efficacy of Extracorporeal Specific Immunoadsorption LupusorbTM Columns for the Treatment of Systemic Lupus Erythematosus (SLE) Patients
Lead Sponsor:
Verto LTD
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune, inflammatory disease primarily affecting women of childbearing age, and associated with severe morbidity and mortality of its victims. The ...
Eligibility Criteria
Inclusion
- Participants, either male or female are at least 18 years of age at entry.
- Have diagnosed documented SLE, determined at least by 4 criteria as defined by the American Rheumatism Association ARA
- Active SLE disease with a SLEDAI score greater than 3
- Serum anti-VRT101 at least 0.4 O.D.
- Be willing and able to comply with the protocol for the duration of the study.
- Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
- If female, must be neither pregnant nor breast-feeding and must lack childbearing potential for the duration of the study.
Exclusion
- Subjects will be excluded from the study if ANY of the following conditions are present:
- Patient has Severe proliferative lupus nephritis:
- Rapidly progressive glomerulonephritis (doubling of serum creatinine during last 3 months); or
- Severe impairment of renal function Cr more than 2.5 mg/dL
- Patient Begin immunosuppressive therapy recently:
- Beginning treatment with azathioprine, mycophenolic acid, cyclosporine or methotrexate within 4 weeks.
- Cyclophosphamide-an IV pulse within the last 3 months
- Pulse therapy with glucocorticoids during the 4 weeks before study entry.
- Patient is in on another experimental therapy.
- Patient suffers an active or chronic infection.
- If female, reports pregnancy, breast-feeding (or inadequate birth control)
- Confounding medical illness that in the judgment of investigators would pose.
- Added risk for study participants such as:
- Unstable coronary artery disease, cardiomyopathy or dysrhythmia requiring therapy
- Hematologic disease (Hb \< 7 G/dL, platelets \< 50,000/dL or WBC \< 2,000/dL).
- Bleeding tendency
- Hypogammaglobulinemia (Serum IgG\< 500mg/dL)
- Participation in another clinical trial within 2 months prior to start of this study.
- Subject unwilling or unable to comply with the requirements of the protocol.
- Any condition that the investigator feels would interfere with trial participation and evaluation of the results.
- Subject unwilling and unable to provide inform consent.
- Subjects receiving ACE inhibitors treatment 7 days prior to plasmapheresis procedure.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00608127
Start Date
January 1 2007
End Date
August 1 2008
Last Update
May 23 2008
Active Locations (1)
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1
Hadassah Ein- Kerem
Jerusalem, Israel, 91120