Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.

Systemic Lupus Erythematosus Clinical Trial

Official title:

Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06228222
• Other study ID #: Predictors of remission in LN.
• Status: Not yet recruiting
• Start date: January 25, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Athanassios Faraj Manassa, MBBS
• Phone: +201097690108
• Email: athanassiosfaraj90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 subjected to the following:

Complete through history taking, clinical examination disease activity will be assessed by SLEDAI. The Laboratory investigations and renal biopsy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis
• Systemic Lupus Erythematosus

Intervention

Procedure:
• 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"

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	25 jan 2024 to 1 oct 2025.
Primary	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.	25 jan 2024 to 1 oct 2025.
Primary	no remission no remission	is defined as not meeting the response criteria.	25 jan 2024 to 1 oct 2025.