Systemic Lupus Erythematosus (SLE)NCT00608127
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
A study testing LupusorbTM in people with Systemic Lupus Erythematosus (SLE), run by Verto LTD at 1 site in Israel.
Trial 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 existing therapy, however, is not specific and its inevitable side effects may themselves be fatal. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- LupusorbTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single - Arm Open - Label 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
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 existing therapy, however, is not specific and its inevitable side effects may themselves be fatal. Therefore, it is a widely recognized need for, and it would be highly advantageous to have a safe, specific rapidly effective and well-defined treatment of SLE, devoid of the disadvantages.
We have shown that VRT101 a peptide present in the extracellular laminin is a target for pathogenic lupus autoantibodies. Using this peptide we have developed the LupusorbTM - an immune-adsorption column which specifically binds pathogenic antibodies from monoclonal cultures as well as from patients' plasma. The investigational product named LupusorbTM Column is a sterile medical device for single use and can be classified into category IIb (synthetic ligands, peptides) according to Annex IX of the European Medical Device Directive 42/93/EEC.
The proposed study, a pilot non-randomized open label study, will test the safety, Tolerability and short term efficacy of a single immunoadsorption procedure in SLE patients.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- LupusorbTM
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LupusorbTMDevice
Single treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single arm open label Receives: Device: LupusorbTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment- Patient's physical examination, vital signs (HR, BP, RR, Rhythm status), lab tests- hematology, CBC & blood biochemistry, Serology panel, anti VRT101 levels, liver and kidney function, urinalysis and SLE serological markers.
Measured: Within 2 months
Secondary outcomes (1)
Efficacy assessment- SLE severity, CBC with differential, ESR, CRP, Blood biochemistry: Serum albumin, Serum Igs, Serology panel: ANA, direct Coomb's; C3, C4, anti-DNA and Serum anti-VRT 101 level and SF 36 Health questionnaire.
Measured: within 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionMay 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verto LTD
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608127
- Sponsor's protocol ID
- LUP-001-ISR
- Status last verified
- May 2008
- First submitted
- 23 Jan 2008
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single - Arm Open - Label 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
- ClinicalTrials.gov ID
- NCT00608127
- Acronym / sponsor ID
- LUP-001-ISR
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Verto LTDIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 existing therapy, however, is not specific and its inevitable side effects may themselves be fatal. Therefore, it is a widely recognized need for, and it would be highly advantageous to have a safe, specific rapidly effective and well-defined treatment of SLE, devoid of the disadvantages.
We have shown that VRT101 a peptide present in the extracellular laminin is a target for pathogenic lupus autoantibodies. Using this peptide we have developed the LupusorbTM - an immune-adsorption column which specifically binds pathogenic antibodies from monoclonal cultures as well as from patients' plasma. The investigational product named LupusorbTM Column is a sterile medical device for single use and can be classified into category IIb (synthetic ligands, peptides) according to Annex IX of the European Medical Device Directive 42/93/EEC.
The proposed study, a pilot non-randomized open label study, will test the safety, Tolerability and short term efficacy of a single immunoadsorption procedure in SLE patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: LupusorbTMSingle arm open label |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (22 listed)
- Patient has Severe proliferative lupus nephritis:
- Patient Begin immunosuppressive therapy recently:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LupusorbTMSingle treatment | Device | 1 |
Primary outcome
Safety assessment- Patient's physical examination, vital signs (HR, BP, RR, Rhythm status), lab tests- hematology, CBC & blood biochemistry, Serology panel, anti VRT101 levels, liver and kidney function, urinalysis and SLE serological markers.
Time frame: Within 2 months
1 secondary outcome
Efficacy assessment- SLE severity, CBC with differential, ESR, CRP, Blood biochemistry: Serum albumin, Serum Igs, Serology panel: ANA, direct Coomb's; C3, C4, anti-DNA and Serum anti-VRT 101 level and SF 36 Health questionnaire.
Time frame: within 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LupusorbTM in people with Systemic Lupus Erythematosus (SLE), run by Verto LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment- Patient's physical examination, vital signs (HR, BP, RR, Rhythm status), lab tests- hematology, CBC & blood biochemistry, Serology panel, anti VRT101 levels, liver and kidney function, urinalysis and SLE serological markers. (time frame: Within 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2008.