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

NCT06228222 | Unknown DMC

• 1 other identifier: Predictors of remission in LN.
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lupus Nephritis; Systemic Lupus Erythematosus

Keywords

lupus nephritis; systemic lupus erythematosus; predictors of outcomes

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• no remission no remission

  is defined as not meeting the response criteria.

  25 jan 2024 to 1 oct 2025.

Study Arms (1)

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).

Procedure: renal biopsy

Interventions

renal biopsy PROCEDURE

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"

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 32153796 BACKGROUND

• 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.

  PMID: 35640982 BACKGROUND

• 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.

  PMID: 28148285 BACKGROUND

• 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.

  PMID: 35658736 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Athanassios Faraj Manassa, MBBS

CONTACT

+201097690108; athanassiosfaraj90@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: January 25, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 29, 2024

Record last verified: 2024-01