Lupus NephritisNCT06228222
Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.
An observational study of Lupus Nephritis and Systemic Lupus Erythematosus, run by Assiut University.
Trial summary
the goal of this opservetional study is to identify predictors of remission and renal outcomes in SLE patients affected with Lupus nephritis. the main question it aims to answer is: *What are the clinical, histological and chemical parameters that connected to undesirable renal prognosis in LN? All patients will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis, Systemic Lupus Erythematosus
- What is being tested?
- renal biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2024to 1 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: the study to be conducted on SLE patients with lupus nephritis who will be admitted to Rheumatology and Nephrology Units, Internal Medicine Department, Assuit university hospitals, Egypt. the SLE patients (classified according to the 1997 American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) with biopsyproven LN (classified according to The revised ISN/RPS 2018 histopathological classification system).
Who may be able to join
- Age > 18 years and SLE patients with biopsy-proven LN.
Who cannot join
- Severe physical disability, patients with uncontrolled hypertension, diabetes mellitus, or severe ischemic heart diseases, patients with mental illness, patients with overlap syndrome, and refusal to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
the goal of this opservetional study is to identify predictors of remission and renal outcomes in SLE patients affected with Lupus nephritis. the main question it aims to answer is:
*What are the clinical, histological and chemical parameters that connected to undesirable renal prognosis in LN?
All patients will be subjected to the following:
Complete through history taking, clinical examination disease activity will be assessed by SLEDAI. The Laboratory investigations and renal biopsy.
Read the detailed description
Systemic lupus erythematosus is a chronic, multisystemic, inflammatory, autoimmune disorder characterized by the formation of autoantibodies directed against self-antigen and immune complex resulting in a wide range of clinical manifestations and target organs (kidney, lungs) damage with unpredictable flares and remissions that eventually lead to permanent injury Lupus nephritis( LN ) is one of the most severe complications in SLE, affecting 35 %- 60 % of the individuals depending on ethnicity, sex, age at the onset of the disease, Course of SLE disease, hereditary factors and nephron cargo and renal toxicity(drug - induced toxicity for example), add to long - term damage of the renal function. LN flares constitute a significant cause of nephron loss, contributing to renal function loss. Recent therapies for LN are not sufficiently effective in preventing or inducing recovery. flares and not all patients show sufficient treatment actions. In fact, fewer than 30 % achieve full recovery within 6 months of treatment. Up to 20 % of patients in recent decades have been affected by LN will eventually develop end - stage renal disease within the first decade of their disease's progression. For this reason, Prediction of the long - term renal outcomes at early stages of the disease is of critical importance. Therefore, many studies have sought to identify early clinical characteristics, lab tests and chemical processes that are connected to undesirable renal prognosis, in order to optimize the monitoring and interventions in these patients. The goals of management of individuals with LN may be divided into short - term ( reduction of flares ) and long - term targets( prevention of renal function impairment ). Currently conducted studies in the field focuses on identifying of clinical, histological and chemical signs of action, damage, treatment response and renal function outcome
All patients will be subjected to the following:
Complete through history taking, clinical examination disease activity will be assessed by SLEDAI. The Laboratory investigations, reported at the time of renal biopsy and after 1, 3, 6 months of treatment:
- complete blood count,
- serum creatinine (SCr)
- SLEDAI
- serum albumin
- C-reactive protein
- urine analysis
- 24-hour urinary protein excretion
- glomerular filtration rate ( eGFR)
- C3 and C4 levels and autoantibody profile, including ANA and anti-dsDNA antibodies,
- Renal biopsy:
Renal biopsy will be performed for all patients fulfilling the American College of Rheumatology (ACR) criteria to confirm the diagnosis of lupus nephritis (LN) and to classify the glomerular disease by "the revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 histopathological classification system" Also, LN class and activity and chronicity scores will be recorded. Patients will be reviewed at one month, three months, and six months for clinical assessment, renal function assessment (SCr and eGFR), assessment of proteinuria, and monitoring response to therapy.
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus
- Being tested
- renal biopsy
- Keywords
- lupus nephritis, systemic lupus erythematosus, predictors of outcomes
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal biopsyProcedure or surgery
Renal biopsy will be performed for all patients fulfilling the American College of Rheumatology (ACR) criteria to confirm the diagnosis of lupus nephritis (LN) and to classify the glomerular disease by "the revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 histopathological classification system"
| Study group | Role | What they receive |
|---|---|---|
| patients | patients with lupus nephritis who will be admitted to Rheumatology and Nephrology Units, Internal Medicine Department, Assuit university hospitals, Egypt. (classified according to the 1997 American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) with biopsyproven LN (classified according to The revised ISN/RPS 2018mhistopathological classification system). Receives: Procedure: renal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission
is defiened as albumin 35 g/l, urinary protein creatinine ratio (UPCR)<0.3g/g, a normal range of SCr or at a level increasing no more than 15% from baseline, and without lupus flares
Measured: 25 jan 2024 to 1 oct 2025.
partial remission
is defined as albumin 30 g/l, a proteinuria > 0.3 but < 3.5 g per 24 hours or decrease 50% from baseline, a normal range of SCr or at a level increasing no more than 25% from the baseline and without lupus flares.
Measured: 25 jan 2024 to 1 oct 2025.
no remission no remission
is defined as not meeting the response criteria.
Measured: 25 jan 2024 to 1 oct 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start25 Jan 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanassios Faraj Manassa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228222
- Sponsor's protocol ID
- Predictors of remission in LN.
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parodis I, Tamirou F, Houssiau FA. Prediction of prognosis and renal outcome in lupus nephritis. Lupus Sci Med. 2020 Feb 18;7(1):e000389. doi: 10.1136/lupus-2020-000389. eCollection 2020.
PubMed 32153796McDonald S, Yiu S, Su L, Gordon C, Truman M, Lisk L, Solomons N, Bruce IN; MASTERPLANS Consortium. Predictors of treatment response in a lupus nephritis population: lessons from the Aspreva Lupus Management Study (ALMS) trial. Lupus Sci Med. 2022 May;9(1):e000584. doi: 10.1136/lupus-2021-000584.
PubMed 35640982Herath N, Ratnatunga N, Weerakoon K, Wazil A, Nanayakkara N. Clinicopathological findings, treatment response and predictors of long-term outcome in a cohort of lupus nephritis patients managed according to the Euro-lupus regime: a retrospective analysis in Sri Lanka. BMC Res Notes. 2017 Feb 2;10(1):80. doi: 10.1186/s13104-017-2402-6.
PubMed 28148285Yadav S, Balakrishnan C, Kothari J. Long-term outcome and predictors of long-term outcome in patients with lupus nephritis managed at a tertiary hospital in Mumbai. Lupus. 2022 Sep;31(10):1191-1201. doi: 10.1177/09612033221106607. Epub 2022 Jun 4.
PubMed 35658736
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.
- ClinicalTrials.gov ID
- NCT06228222
- Acronym / sponsor ID
- Predictors of remission in LN.
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus
- Keywords
- lupus nephritis, systemic lupus erythematosus, predictors of outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Jan 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.
the goal of this opservetional study is to identify predictors of remission and renal outcomes in SLE patients affected with Lupus nephritis. the main question it aims to answer is:
*What are the clinical, histological and chemical parameters that connected to undesirable renal prognosis in LN?
All patients will be subjected to the following:
Complete through history taking, clinical examination disease activity will be assessed by SLEDAI. The Laboratory investigations and renal biopsy.
Detailed description
Systemic lupus erythematosus is a chronic, multisystemic, inflammatory, autoimmune disorder characterized by the formation of autoantibodies directed against self-antigen and immune complex resulting in a wide range of clinical manifestations and target organs (kidney, lungs) damage with unpredictable flares and remissions that eventually lead to permanent injury Lupus nephritis( LN ) is one of the most severe complications in SLE, affecting 35 %- 60 % of the individuals depending on ethnicity, sex, age at the onset of the disease, Course of SLE disease, hereditary factors and nephron cargo and renal toxicity(drug - induced toxicity for example), add to long - term damage of the renal function. LN flares constitute a significant cause of nephron loss, contributing to renal function loss. Recent therapies for LN are not sufficiently effective in preventing or inducing recovery. flares and not all patients show sufficient treatment actions. In fact, fewer than 30 % achieve full recovery within 6 months of treatment. Up to 20 % of patients in recent decades have been affected by LN will eventually develop end - stage renal disease within the first decade of their disease's progression. For this reason, Prediction of the long - term renal outcomes at early stages of the disease is of critical importance. Therefore, many studies have sought to identify early clinical characteristics, lab tests and chemical processes that are connected to undesirable renal prognosis, in order to optimize the monitoring and interventions in these patients. The goals of management of individuals with LN may be divided into short - term ( reduction of flares ) and long - term targets( prevention of renal function impairment ). Currently conducted studies in the field focuses on identifying of clinical, histological and chemical signs of action, damage, treatment response and renal function outcome
All patients will be subjected to the following:
Complete through history taking, clinical examination disease activity will be assessed by SLEDAI. The Laboratory investigations, reported at the time of renal biopsy and after 1, 3, 6 months of treatment:
- complete blood count,
- serum creatinine (SCr)
- SLEDAI
- serum albumin
- C-reactive protein
- urine analysis
- 24-hour urinary protein excretion
- glomerular filtration rate ( eGFR)
- C3 and C4 levels and autoantibody profile, including ANA and anti-dsDNA antibodies,
- Renal biopsy:
Renal biopsy will be performed for all patients fulfilling the American College of Rheumatology (ACR) criteria to confirm the diagnosis of lupus nephritis (LN) and to classify the glomerular disease by "the revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 histopathological classification system" Also, LN class and activity and chronicity scores will be recorded. Patients will be reviewed at one month, three months, and six months for clinical assessment, renal function assessment (SCr and eGFR), assessment of proteinuria, and monitoring response to therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: renal biopsypatients with lupus nephritis who will be admitted to Rheumatology and Nephrology Units, Internal Medicine Department, Assuit university hospitals, Egypt. (classified according to the 1997 American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) with biopsyproven LN (classified according to The revised ISN/RPS 2018mhistopathological classification system). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study to be conducted on SLE patients with lupus nephritis who will be admitted to Rheumatology and Nephrology Units, Internal Medicine Department, Assuit university hospitals, Egypt. the SLE patients (classified according to the 1997 American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) with biopsyproven LN (classified according to The revised ISN/RPS 2018 histopathological classification system).
Key inclusion criteria (1 listed)
- Age > 18 years and SLE patients with biopsy-proven LN.
Key exclusion criteria (1 listed)
- Severe physical disability, patients with uncontrolled hypertension, diabetes mellitus, or severe ischemic heart diseases, patients with mental illness, patients with overlap syndrome, and refusal to participate in the study.
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 |
|---|---|---|
| renal biopsyRenal biopsy will be performed for all patients fulfilling the American College of Rheumatology (ACR) criteria to confirm the diagnosis of lupus nephritis (LN) and to classify the glomerular disease by "the revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 histopathological classification system" | Procedure or surgery | patients |
Primary outcome
Complete remission
Time frame: 25 jan 2024 to 1 oct 2025.
is defiened as albumin 35 g/l, urinary protein creatinine ratio (UPCR)<0.3g/g, a normal range of SCr or at a level increasing no more than 15% from baseline, and without lupus flares
partial remission
Time frame: 25 jan 2024 to 1 oct 2025.
is defined as albumin 30 g/l, a proteinuria > 0.3 but < 3.5 g per 24 hours or decrease 50% from baseline, a normal range of SCr or at a level increasing no more than 25% from the baseline and without lupus flares.
no remission no remission
Time frame: 25 jan 2024 to 1 oct 2025.
is defined as not meeting the response criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 32153796Parodis I, Tamirou F, Houssiau FA. Prediction of prognosis and renal outcome in lupus nephritis. Lupus Sci Med. 2020 Feb 18;7(1):e000389. doi: 10.1136/lupus-2020-000389. eCollection 2020.
- Background: PubMed 35640982McDonald S, Yiu S, Su L, Gordon C, Truman M, Lisk L, Solomons N, Bruce IN; MASTERPLANS Consortium. Predictors of treatment response in a lupus nephritis population: lessons from the Aspreva Lupus Management Study (ALMS) trial. Lupus Sci Med. 2022 May;9(1):e000584. doi: 10.1136/lupus-2021-000584.
- Background: PubMed 28148285Herath N, Ratnatunga N, Weerakoon K, Wazil A, Nanayakkara N. Clinicopathological findings, treatment response and predictors of long-term outcome in a cohort of lupus nephritis patients managed according to the Euro-lupus regime: a retrospective analysis in Sri Lanka. BMC Res Notes. 2017 Feb 2;10(1):80. doi: 10.1186/s13104-017-2402-6.
- Background: PubMed 35658736Yadav S, Balakrishnan C, Kothari J. Long-term outcome and predictors of long-term outcome in patients with lupus nephritis managed at a tertiary hospital in Mumbai. Lupus. 2022 Sep;31(10):1191-1201. doi: 10.1177/09612033221106607. Epub 2022 Jun 4.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis and Systemic Lupus Erythematosus, 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 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: status not confirmed, as of the sponsor's last update on 29 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athanassios Faraj Manassa, MBBS (+201097690108, athanassiosfaraj90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (time frame: 25 jan 2024 to 1 oct 2025.). 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?
On the ClinicalTrials.gov record for NCT06228222, 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 29 Jan 2024.