Systemic LupusNCT03164720
SSerum/Urinary Monocyte Chemoattractant Protein-1 Level as a Marker for Lupus Nephritis
An observational study of Systemic Lupus, run by Assiut University.
Trial summary
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild manifestations (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to 1 Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This study will include 60 patients with renal biopsy proven LN or without LN by laboratory investigation together with 20 healthy control age and sex matched with the patients.
Who may be able to join
- revised American Collage of Rheumatology classification criteria for SLE
Who cannot join
- Patients with diabetes mellitus.
- patients with a diagnosis of overlap syndrome (coexistence of lupus with other connective tissue diseases such as rheumatoid arthritis or scleroderma)..
- Patients with urinary tract infection.
- Patients with end stage renal disease.
About this study
Official title: Serum/Urinary Monocyte Chemoattractant Protein-1 Level as a Marker for Lupus Nephritis
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN is one of the most serious SLE complications since it is the major predictor of poor prognosis .
Lupus nephritis is a common major organ manifestation and main cause of morbidity and mortality of the disease . It is occurred in 30-50% of SLE patients at initial diagnosis and more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year survival rate of a patient with severe LN is less than70-80%. Therefore, an involvement of renal disease activity is one of the most important prognostic factors for patients with SLE, and the diagnosis of SLE patients with LN has an important clinical implication in guiding the treatment of SLE in clinical settings.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN is one of the most serious SLE complications since it is the major predictor of poor prognosis .
Lupus nephritis is a common major organ manifestation and main cause of morbidity and mortality of the disease. It is occurred in 30-50% of SLE patients at initial diagnosis and more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year survival rate of a patient with severe LN is less than70-80% . Therefore, the diagnosis of SLE patients with LN has an important clinical implication in guiding the treatment of SLE in clinical settings.
Renal biopsies have remained the "gold standard" of assessing lupus nephritis (LN) patients not only at diagnosis but also to assess the efficacy of treatment. In contrast, current noninvasive laboratory markers for LN such as proteinuria, urine protein to creatinine ratio, creatinine clearance, antidsDNA, and complement levels are unsatisfactory because they lack sensitivity and specificity for differentiating renal activity and damage in LN.
The search for an accurate and reliable biomarker for lupus nephritis is particularly important since the only reliable method to evaluate it is by performing a kidney biopsy, that is an invasive procedure may not always be feasible. So significant effort has been put into identifying biomarkers that can anticipate impending lupus renal flare, forecast development of chronic kidney disease, or reflect kidney histology at time of flare .
Monocyte chemoattractant protein-1 (MCP1) is a chemokine that attracts monocytes/macrophages to sites of inflammation. MCP-1 is produced by mesangial, podocyte, and monocyte cells in response to various proinflammatory stimuli such as tumor necrosis factor alpha (TNF-
- Conditions
- Systemic Lupus
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum/Urinary monocyte chemoattractant protein-1 level as a marker for lupus nephritis
- Determine the levels of serum / urinary MCP-1 in patients with systemic lupus erythematosus
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startJun 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic LupusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164720
- Sponsor's protocol ID
- assiut 8080
- Status last verified
- Jan 2019
- First submitted
- 22 May 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: use Serum/Urinary monocyte chemoattractant protein-1 level as a marker for lupus nephritis
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum/Urinary Monocyte Chemoattractant Protein-1 Level as a Marker for Lupus Nephritis
- ClinicalTrials.gov ID
- NCT03164720
- Acronym / sponsor ID
- assiut 8080
- Conditions
- Systemic Lupus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 24 May 2017 (actual)
- 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 inflammatory autoimmune disease affecting many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN is one of the most serious SLE complications since it is the major predictor of poor prognosis .
Lupus nephritis is a common major organ manifestation and main cause of morbidity and mortality of the disease . It is occurred in 30-50% of SLE patients at initial diagnosis and more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year survival rate of a patient with severe LN is less than70-80%. Therefore, an involvement of renal disease activity is one of the most important prognostic factors for patients with SLE, and the diagnosis of SLE patients with LN has an important clinical implication in guiding the treatment of SLE in clinical settings.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN is one of the most serious SLE complications since it is the major predictor of poor prognosis .
Lupus nephritis is a common major organ manifestation and main cause of morbidity and mortality of the disease. It is occurred in 30-50% of SLE patients at initial diagnosis and more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year survival rate of a patient with severe LN is less than70-80% . Therefore, the diagnosis of SLE patients with LN has an important clinical implication in guiding the treatment of SLE in clinical settings.
Renal biopsies have remained the "gold standard" of assessing lupus nephritis (LN) patients not only at diagnosis but also to assess the efficacy of treatment. In contrast, current noninvasive laboratory markers for LN such as proteinuria, urine protein to creatinine ratio, creatinine clearance, antidsDNA, and complement levels are unsatisfactory because they lack sensitivity and specificity for differentiating renal activity and damage in LN.
The search for an accurate and reliable biomarker for lupus nephritis is particularly important since the only reliable method to evaluate it is by performing a kidney biopsy, that is an invasive procedure may not always be feasible. So significant effort has been put into identifying biomarkers that can anticipate impending lupus renal flare, forecast development of chronic kidney disease, or reflect kidney histology at time of flare .
Monocyte chemoattractant protein-1 (MCP1) is a chemokine that attracts monocytes/macrophages to sites of inflammation. MCP-1 is produced by mesangial, podocyte, and monocyte cells in response to various proinflammatory stimuli such as tumor necrosis factor alpha (TNF-
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will include 60 patients with renal biopsy proven LN or without LN by laboratory investigation together with 20 healthy control age and sex matched with the patients.
Key inclusion criteria (1 listed)
- revised American Collage of Rheumatology classification criteria for SLE
Key exclusion criteria (4 listed)
- Patients with diabetes mellitus.
- patients with a diagnosis of overlap syndrome (coexistence of lupus with other connective tissue diseases such as rheumatoid arthritis or scleroderma)..
- Patients with urinary tract infection.
- Patients with end stage renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum/Urinary monocyte chemoattractant protein-1 level as a marker for lupus nephritis
Time frame: one year
- Determine the levels of serum / urinary MCP-1 in patients with systemic lupus erythematosus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Undecided. use Serum/Urinary monocyte chemoattractant protein-1 level as a marker for lupus nephritis
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus, run by Assiut University.
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 1 inclusion and 4 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Serum/Urinary monocyte chemoattractant protein-1 level as a marker for lupus nephritis (time frame: one year). 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 15 Jan 2019.