Lupus Nephritis (LN)NCT06588192
Renal Survival in Patients with Lupus Nephritis
An observational study of Lupus Nephritis (LN), run by Assiut University.
Trial summary
Systemic lupus erythematous is a chronic multifactorial autoimmune disease that affects many organs including kidney. Lupus nephritis is a common manifestation characterized by heterogeneous clinical and histopathological finding and often associate with poor progression and despite potent anti-inflammatory and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis (LN)
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: nephrology department, Assiut University Hospital inpatient and outpatient clinics
Who may be able to join
- Age\>18years old
- Patients with SLE as defined by EULAR/ACR criteria and lupus nephritis classification according to ISN/RPS classification.
- Available medical records for 2 and 5 years of follow up after diagnosis of lupus nephritis
Who cannot join
- Transplant recipients
- Pregnant females
- Patients with combined renal pathology other than LN.
- Those who had no baseline information in hospital medical records and had a follow up duration \< 24 months will be excluded
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: Renal Survival in Patients with Lupus Nephritis in Assiut University Hospital: a Single-center Study
Systemic lupus erythematous is a chronic multifactorial autoimmune disease that affects many organs including kidney. Lupus nephritis is a common manifestation characterized by heterogeneous clinical and histopathological finding and often associate with poor progression and despite potent anti-inflammatory and immunosuppressive therapies still end in CKD or ESRD for too many patient. lupus nephritis is an immune complex GN that develop as a frequent complication of SLE. The pathogenesis of lupus nephritis involve a variety of pathogenic mechanisms, intra renal pathomechanisn of SLE related nephritis immune complex formation and classical complement pathway activation. Lupus nephritis doesn\'t develop in the absence of antinuclear antibodies. Circulating polyclonal autoantibodies bind to intrarenal nucleosomes and other autoantigen, which lead to local complement activation , cell injury and subsequent cytokine and chemokine secretion . The current management of lupus nephritis remain based on steroids, cyclophosphamide, azathioprine ,mycophenolate mefetile which are all unselective immunosuppressive drugs, these drugs have proven to be efficient in reducing lupus nephritis disease activity but the long term outcomes of lupus nephritis have not further improved during the last 30 years . Identification of renal survival is mandatory for certain purposes i.e, evaluation of efficacy of different treatment strategies among our patients and factors associated with the survival data as compared with other specialized centers.
Read the detailed description
Systemic lupus erythematous is a chronic multifactorial autoimmune disease that affects many organs including kidney. Lupus nephritis is a common manifestation characterized by heterogeneous clinical and histopathological finding and often associate with poor progression and despite potent anti-inflammatory and immunosuppressive therapies still end in CKD or ESRD for too many patient. lupus nephritis is an immune complex GN that develop as a frequent complication of SLE. The pathogenesis of lupus nephritis involve a variety of pathogenic mechanisms, intra renal pathomechanisn of SLE related nephritis immune complex formation and classical complement pathway activation. Lupus nephritis doesn\'t develop in the absence of antinuclear antibodies. Circulating polyclonal autoantibodies bind to intrarenal nucleosomes and other autoantigen, which lead to local complement activation , cell injury and subsequent cytokine and chemokine secretion . The current management of lupus nephritis remain based on steroids, cyclophosphamide, azathioprine ,mycophenolate mefetile which are all unselective immunosuppressive drugs, these drugs have proven to be efficient in reducing lupus nephritis disease activity but the long term outcomes of lupus nephritis have not further improved during the last 30 years . Identification of renal survival is mandatory for certain purposes i.e, evaluation of efficacy of different treatment strategies among our patients and factors associated with the survival data as compared with other specialized centers.
- Conditions
- Lupus Nephritis (LN)
- Keywords
- lupus, nephritis
- Medical subject headings
- Lupus Nephritis, Nephritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of two and five years renal survival among patients with lupus nephritis
Measured: 2-5 years observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lupus Nephritis (LN)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Soudy Ahmed Hmad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588192
- Sponsor's protocol ID
- survival in lupus nephritis
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mahajan A, Amelio J, Gairy K, Kaur G, Levy RA, Roth D, Bass D. Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: a pragmatic review mapping disease severity and progression. Lupus. 2020 Aug;29(9):1011-1020. doi: 10.1177/0961203320932219. Epub 2020 Jun 22.
PubMed 32571142Aringer M. EULAR/ACR classification criteria for SLE. Semin Arthritis Rheum. 2019 Dec;49(3S):S14-S17. doi: 10.1016/j.semarthrit.2019.09.009.
PubMed 31779843Yu C, Li P, Dang X, Zhang X, Mao Y, Chen X. Lupus nephritis: new progress in diagnosis and treatment. J Autoimmun. 2022 Oct;132:102871. doi: 10.1016/j.jaut.2022.102871. Epub 2022 Aug 20.
PubMed 35999111Liu Y, Anders HJ. Lupus nephritis: from pathogenesis to targets for biologic treatment. Nephron Clin Pract. 2014;128(3-4):224-31. doi: 10.1159/000368581. Epub 2014 Nov 8.
PubMed 25401461
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Survival in Patients with Lupus Nephritis in Assiut University Hospital: a Single-center Study
- ClinicalTrials.gov ID
- NCT06588192
- Acronym / sponsor ID
- survival in lupus nephritis
- Conditions
- Lupus Nephritis (LN)
- Keywords
- lupus, nephritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 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.
Systemic lupus erythematous is a chronic multifactorial autoimmune disease that affects many organs including kidney. Lupus nephritis is a common manifestation characterized by heterogeneous clinical and histopathological finding and often associate with poor progression and despite potent anti-inflammatory and immunosuppressive therapies still end in CKD or ESRD for too many patient. lupus nephritis is an immune complex GN that develop as a frequent complication of SLE. The pathogenesis of lupus nephritis involve a variety of pathogenic mechanisms, intra renal pathomechanisn of SLE related nephritis immune complex formation and classical complement pathway activation. Lupus nephritis doesn\'t develop in the absence of antinuclear antibodies. Circulating polyclonal autoantibodies bind to intrarenal nucleosomes and other autoantigen, which lead to local complement activation , cell injury and subsequent cytokine and chemokine secretion . The current management of lupus nephritis remain based on steroids, cyclophosphamide, azathioprine ,mycophenolate mefetile which are all unselective immunosuppressive drugs, these drugs have proven to be efficient in reducing lupus nephritis disease activity but the long term outcomes of lupus nephritis have not further improved during the last 30 years . Identification of renal survival is mandatory for certain purposes i.e, evaluation of efficacy of different treatment strategies among our patients and factors associated with the survival data as compared with other specialized centers.
Detailed description
Systemic lupus erythematous is a chronic multifactorial autoimmune disease that affects many organs including kidney. Lupus nephritis is a common manifestation characterized by heterogeneous clinical and histopathological finding and often associate with poor progression and despite potent anti-inflammatory and immunosuppressive therapies still end in CKD or ESRD for too many patient. lupus nephritis is an immune complex GN that develop as a frequent complication of SLE. The pathogenesis of lupus nephritis involve a variety of pathogenic mechanisms, intra renal pathomechanisn of SLE related nephritis immune complex formation and classical complement pathway activation. Lupus nephritis doesn\'t develop in the absence of antinuclear antibodies. Circulating polyclonal autoantibodies bind to intrarenal nucleosomes and other autoantigen, which lead to local complement activation , cell injury and subsequent cytokine and chemokine secretion . The current management of lupus nephritis remain based on steroids, cyclophosphamide, azathioprine ,mycophenolate mefetile which are all unselective immunosuppressive drugs, these drugs have proven to be efficient in reducing lupus nephritis disease activity but the long term outcomes of lupus nephritis have not further improved during the last 30 years . Identification of renal survival is mandatory for certain purposes i.e, evaluation of efficacy of different treatment strategies among our patients and factors associated with the survival data as compared with other specialized centers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- nephrology department, Assiut University Hospital inpatient and outpatient clinics
Key inclusion criteria (3 listed)
- Age\>18years old
- Patients with SLE as defined by EULAR/ACR criteria and lupus nephritis classification according to ISN/RPS classification.
- Available medical records for 2 and 5 years of follow up after diagnosis of lupus nephritis
Key exclusion criteria (4 listed)
- Transplant recipients
- Pregnant females
- Patients with combined renal pathology other than LN.
- Those who had no baseline information in hospital medical records and had a follow up duration \< 24 months will be excluded
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
Assessment of two and five years renal survival among patients with lupus nephritis
Time frame: 2-5 years observation
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 19 Sep 2024.
- Background: PubMed 32571142Mahajan A, Amelio J, Gairy K, Kaur G, Levy RA, Roth D, Bass D. Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: a pragmatic review mapping disease severity and progression. Lupus. 2020 Aug;29(9):1011-1020. doi: 10.1177/0961203320932219. Epub 2020 Jun 22.
- Background: PubMed 31779843Aringer M. EULAR/ACR classification criteria for SLE. Semin Arthritis Rheum. 2019 Dec;49(3S):S14-S17. doi: 10.1016/j.semarthrit.2019.09.009.
- Background: PubMed 35999111Yu C, Li P, Dang X, Zhang X, Mao Y, Chen X. Lupus nephritis: new progress in diagnosis and treatment. J Autoimmun. 2022 Oct;132:102871. doi: 10.1016/j.jaut.2022.102871. Epub 2022 Aug 20.
- Background: PubMed 25401461Liu Y, Anders HJ. Lupus nephritis: from pathogenesis to targets for biologic treatment. Nephron Clin Pract. 2014;128(3-4):224-31. doi: 10.1159/000368581. Epub 2014 Nov 8.
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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 (LN), 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 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: opening soon, as of the sponsor's last update on 19 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 Gehad Gehad soudy Ahmed hmad (01013354295, soudygehad125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of two and five years renal survival among patients with lupus nephritis (time frame: 2-5 years observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588192, which also lists 4 linked publications.
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 19 Sep 2024.