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

January 19, 2024 updated by: Athanassios Faraj Manassa, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
25 jan 2024 to 1 oct 2025.
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.
25 jan 2024 to 1 oct 2025.
no remission no remission
Time Frame: 25 jan 2024 to 1 oct 2025.
is defined as not meeting the response criteria.
25 jan 2024 to 1 oct 2025.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Predictors of remission in LN.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on renal biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe