Lupus NephritisNCT06610422
Association Between Neuropathy and Some Autoantibodies in Systemic Lupus Erythematosus (SLE) Patients
An observational study of Lupus Nephritis, run by Assiut University.
Trial summary
1. Frequency of peripheral neuropathy associated with lupus nephritis 2. Sensitivity and specificity of some biomarkers used in diagnosis and follow up of SLE with lupus nephritis and peripheral neuropathy Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lupus Nephritis
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- Adult, Older adult
Study population: Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ):patients demographics including )age ,sex , residence , occupation,age at time of diagnosis) Full history and examination Laboratory data \& Investigations 1. CBC 2. Kidney function tests 3. ESR 4. CRP 5. urine analysis 6. screening for (HBv- HcV-HIV) 7. Autoantibodies: ANA , Anti- ds DNA 8. Rheumatoid factor 9. neuromuscular ultrasound 10 - nerve conduction
Who may be able to join
- 1. Female patients
- 2. Age ≥ 18 years
- 3. Patients diagnosed as SLE and lupus nephritis as clinical, laboratory investigations and renal biopsy for indicated cases 4. Anti phospholipid antibodies (IgG \& IgM) 5.Associated vasculitis ( cANCA \& pANCA ) 6.Active - inactive classes of SLE 7.CKD stage I \& IV not on dialysis
Who cannot join
- 1.history of viral hepatitis B or C 2.A history of malignancy (excluding basal cell carcinoma) 3.pulse therapy 4.chronic kidney disease (CKD) stage 5 or hemodialysis 5.SLE not associated with renal affect
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Neuropathy and Some Autoantibodies in Systemic Lupus Erythematosus (SLE) Patients With Lupus Nephritis in Assiut University Hospital
- Frequency of peripheral neuropathy associated with lupus nephritis
- Sensitivity and specificity of some biomarkers used in diagnosis and follow up of SLE with lupus nephritis and peripheral neuropathy
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic, inflammatory,autoimmune disease that is characterized by multisystemic involvement with diverse clinical presentation .
Peripheral neuropathy is a well-documented clinical manifestation of systemic lupus erythematosus (SLE) , with a prevalence rate ranging from 2% to 27.8% . Several lines of evidence link the risk of neuropathy with the antiphospholipid antibody and rheumatoid factor , as well as neuropsychiatric lupus with anti-Ro . Some evidence links anti-ganglioside antibodies with neuropathy , but other studies do not . Peripheral neuropathy may be slowly progressive or acutely devastating . Lupus nephritis (LN), a more definite and specific subgroup of lupus, is a major cause of morbidity and mortality in SLE and can affect up to 60% of SLE patients. Furthermore, the presence of peripheral neuropathy in LN patients may be relevant for improving their lives . Such complex situation poses a therapeutic challenge. The clinical presentation of PN relies upon the diameter of the affected nerve, the sort of demyelinating or axonal lesions, and their acute or chronic occurrence . Routine nerve conduction studies just mirror the activity of the fast conducting myelinated A nerve fibers, which are physiologically irrelevant to pain. Hence, quantitative sensory testing can evaluate small nerve fiber function The pathogenesis of SLE-related neuropathy is obscure, and the few pathological studies of the peripheral nerves in SLE have revealed axonal degeneration, inflammatory changes, and vasculitis .
The major inflammatory mediators released from immune cells act on sensory neurons, inducing peripheral sensitization and hyperalgesic phenomena. In addition, after damage, this natural inflammatory response could encourage the pathogenetic activity of antineural autoantibodies, in addition to ischemic vascular mechanism, by vasa nervorum vascularitis or by microthrombi linked to antiphospholipid antibodies.
The other legitimate mechanisms are immunologic cause by a direct aggression by antibodies, entraining obliteration of the peripheral nerve component.
Furthermore, the PN has not been well prescribed in SLE in terms of onset, severity, clinical associations, and electrophysiological characteristics.. Therefore, we are going to characterize PN in SLE with respect to the patient's clinical lupus properties, serologic markers, disease activity, and electrophysiological data
- Conditions
- Lupus Nephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inactive stage | patients diagnosed as SLE and lupus nephritis (inactive stage) | |
| Active stage | patients diagnosed as SLE and lupus nephritis (active stage) | |
| Control | patients control group not SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nephropathy and autoantibodies
1- Relation between neuropathy and autoantibodies in lupus nephritis
Measured: through study completion, an average of 1 year]]
Prepherial nephropathy and systemic lupus
Evaluate the frequency and severity of symptoms of peripheral neuropathy among patients with lupus nephritis
Measured: through study completion, an average of 1 year]
Electrophysiology
Study electrophysiological properties of peripheral neuropathy and their relation to disease activity
Measured: through study completion, an average of 1 year]]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study startJan 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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
- Cross-sectional
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Asaad Fahmy Sedhom, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610422
- Sponsor's protocol ID
- Nephropathy and systemic lupus
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Neuropathy and Some Autoantibodies in Systemic Lupus Erythematosus (SLE) Patients With Lupus Nephritis in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06610422
- Acronym / sponsor ID
- Nephropathy and systemic lupus
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Sep 2024 (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.
- Frequency of peripheral neuropathy associated with lupus nephritis
- Sensitivity and specificity of some biomarkers used in diagnosis and follow up of SLE with lupus nephritis and peripheral neuropathy
Detailed description
Systemic lupus erythematosus (SLE) is a chronic, inflammatory,autoimmune disease that is characterized by multisystemic involvement with diverse clinical presentation .
Peripheral neuropathy is a well-documented clinical manifestation of systemic lupus erythematosus (SLE) , with a prevalence rate ranging from 2% to 27.8% . Several lines of evidence link the risk of neuropathy with the antiphospholipid antibody and rheumatoid factor , as well as neuropsychiatric lupus with anti-Ro . Some evidence links anti-ganglioside antibodies with neuropathy , but other studies do not . Peripheral neuropathy may be slowly progressive or acutely devastating . Lupus nephritis (LN), a more definite and specific subgroup of lupus, is a major cause of morbidity and mortality in SLE and can affect up to 60% of SLE patients. Furthermore, the presence of peripheral neuropathy in LN patients may be relevant for improving their lives . Such complex situation poses a therapeutic challenge. The clinical presentation of PN relies upon the diameter of the affected nerve, the sort of demyelinating or axonal lesions, and their acute or chronic occurrence . Routine nerve conduction studies just mirror the activity of the fast conducting myelinated A nerve fibers, which are physiologically irrelevant to pain. Hence, quantitative sensory testing can evaluate small nerve fiber function The pathogenesis of SLE-related neuropathy is obscure, and the few pathological studies of the peripheral nerves in SLE have revealed axonal degeneration, inflammatory changes, and vasculitis .
The major inflammatory mediators released from immune cells act on sensory neurons, inducing peripheral sensitization and hyperalgesic phenomena. In addition, after damage, this natural inflammatory response could encourage the pathogenetic activity of antineural autoantibodies, in addition to ischemic vascular mechanism, by vasa nervorum vascularitis or by microthrombi linked to antiphospholipid antibodies.
The other legitimate mechanisms are immunologic cause by a direct aggression by antibodies, entraining obliteration of the peripheral nerve component.
Furthermore, the PN has not been well prescribed in SLE in terms of onset, severity, clinical associations, and electrophysiological characteristics.. Therefore, we are going to characterize PN in SLE with respect to the patient's clinical lupus properties, serologic markers, disease activity, and electrophysiological data
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactive stage | – | –patients diagnosed as SLE and lupus nephritis (inactive stage) |
| Active stage | – | –patients diagnosed as SLE and lupus nephritis (active stage) |
| Control | – | –patients control group not SLE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ):patients demographics including )age ,sex , residence , occupation,age at time of diagnosis) Full history and examination Laboratory data \& Investigations 1. CBC 2. Kidney function tests 3. ESR 4. CRP 5. urine analysis 6. screening for (HBv- HcV-HIV) 7. Autoantibodies: ANA , Anti- ds DNA 8. Rheumatoid factor 9. neuromuscular ultrasound 10 - nerve conduction
Key inclusion criteria (3 listed)
- 1. Female patients
- 2. Age ≥ 18 years
- 3. Patients diagnosed as SLE and lupus nephritis as clinical, laboratory investigations and renal biopsy for indicated cases 4. Anti phospholipid antibodies (IgG \& IgM) 5.Associated vasculitis ( cANCA \& pANCA ) 6.Active - inactive classes of SLE 7.CKD stage I \& IV not on dialysis
Key exclusion criteria (1 listed)
- 1.history of viral hepatitis B or C 2.A history of malignancy (excluding basal cell carcinoma) 3.pulse therapy 4.chronic kidney disease (CKD) stage 5 or hemodialysis 5.SLE not associated with renal affect
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
Nephropathy and autoantibodies
Time frame: through study completion, an average of 1 year]]
1- Relation between neuropathy and autoantibodies in lupus nephritis
Prepherial nephropathy and systemic lupus
Time frame: through study completion, an average of 1 year]
Evaluate the frequency and severity of symptoms of peripheral neuropathy among patients with lupus nephritis
Electrophysiology
Time frame: through study completion, an average of 1 year]]
Study electrophysiological properties of peripheral neuropathy and their relation to disease activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina A Fahmy (01093635485, asadmarina269@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nephropathy and autoantibodies (time frame: through study completion, an average of 1 year]]). The study lists 3 primary outcomes in all. 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 24 Sep 2024.