Clinical trial NCT06228222: Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.
Official title: Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lupus Nephritis
Systemic Lupus Erythematosus
Keywords: lupus nephritis
systemic lupus erythematosus
predictors of outcomes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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 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:

1. complete blood count,
2. serum creatinine (SCr)
3. SLEDAI
4. serum albumin
5. C-reactive protein
6. urine analysis
7. 24-hour urinary protein excretion
8. glomerular filtration rate ( eGFR)
9. C3 and C4 levels and autoantibody profile, including ANA and anti-dsDNA antibodies,
10. 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years and SLE patients with biopsy-proven LN.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Complete remission
timeFrame: 25 jan 2024 to 1 oct 2025.
measure: partial remission
timeFrame: 25 jan 2024 to 1 oct 2025.
measure: no remission no remission
timeFrame: 25 jan 2024 to 1 oct 2025.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: McDonald 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.
citation: Herath 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.
citation: Yadav 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.