Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients

February 27, 2024 updated by: Asmaa Nabil Badr, Assiut University
  • Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment.
  • Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.
  • Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment.
  • Correlation between detected markers and other assessment tools.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic sclerosis (SSc) is an autoimmune disease characterized by endothelial dysfunction, collagen deposition, and fibrosis in the skin and internal organs. Systemic lupus erythematosus (SLE) is a complex, multi-organ autoimmune disease. The presence of autoantibodies and circulating immune complexes can cause vasculitis and damage the endothelial cells, leading to multiple organ dysfunctions. Renal involvement in SSc, ranges from urinary abnormalities, reduction of glomerular filtration rate (GFR), and high resistive indices, to scleroderma renal crisis (SRC). Subclinical renal vasculopathy is characterized by progressive increase of intrarenal stiffness and reduction of parenchymal thickness due to post ischemic fibrosis secondary to the renal Raynaud phenomenon.Conversely, in SLE-related kidney manifestations, renal damage results from glomerular involve-ment secondary to immune-complex acti¬vation. Cluster of differentiation 147 (CD147) is, also named extracellular matrix metalloproteinase inducer (EMMPRIN), a transmembrane glycoprotein in the immunoglobulin superfamily that is widely expressed on the surface membrane of various cells. Higher levels of soluble CD147 were found in SSc patients compared to healthy controls and higher levels in SSc patients with scleroderma renal crisis (SRC). Suggesting that CD147 could be a useful tool for identifying SRC risk. In patients with active SLE, CD147 is overexpressed on CD3 T lymphocytes. Renal resistive index (RRI) is a useful non-invasive technique for evaluation of renal disease activity in SLE patients. It can differentiate between patients with active lupus nephritis (LN) and inactive LN. RRI was higher in SSc patients than other autoimmune diseases since subclinical renal vasculopathy is the main pathogenic mecha¬nism of all SSc renal manifestations.Multiparametric renal Magnetic Resonance Imaging (MRI) shows great promise as a non-invasive method to assess kidney structure and function without exposure to radiation or gadolinium contrast agents. In MRI microstructural changes of lupus nephritis kidney such as inflammatory cell infiltration or fibrosis could influence water molecular movement or diffusion, which indicates that diffusion-weigted imaging (DWI) may become a valuable tool in diagnosis of LN. However in systemic sclerosis there is decline of renal blood flow values that indicate microvascular pathology.

Study Type

Observational

Enrollment (Estimated)

95

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

Study Contact Backup

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

N/A

Sampling Method

Non-Probability Sample

Study Population

The study will include adult SSc and SLE patients consecutively presented at the rheumatology, rehabilitation and physical medicine department, Assiut university hospital from both inpatient department and outpatient clinic

Description

Inclusion Criteria:

  1. Adult (aged above 18 years) SSc patients who fulfilled the 2013 European League Against Rheumatism/American College of Rheumatology (EULAR / ACR) for SSC [13] and 1980 ACR criteria [14].
  2. Adult SLE Patients who fulfilled the 2019 EULAR / ACR classification criteria for systemic lupus erythematosus [15]

Exclusion Criteria:

  1. Individuals with other autoimmune diseases.
  2. Smoking.
  3. Infections as chest infection, hepatitis C, hepatitis B and HIV infection.
  4. Tumors as hepatocellular carcinoma.
  5. Hypertension, diabetes, heart failure, hepatic diseases, chronic renal failure, intrarenal arteriovenous fistula, obstructive nephropathy and urinary tract obstruction.
  6. Contraindication for MRI as implanted metallic devices.

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
systemic sclerosis patients

Adult (aged above 18 years) SSc patients who fulfilled the 2013 European League Against Rheumatism/American College of Rheumatology (EULAR / ACR) for SSC and 1980 ACR criteria.

-SSc patients will be subjected to 2017 European Scleroderma Trials and Research group (EUSTAR) activity index
Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147

Laboratory investigations:

erythrocyte sedimentation rate (ESR) Serum C-reactive protein (CRP) complete blood picture (CBC) liver function tests (LFT): aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin.

kidney function tests (KFT): serum creatinine and blood urea. Estimated glomerular filteration rate (eGFR) by CKD-EPI Creatinine Equation (2021).

Complete urine analysis for: proteinuria, urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field).

24 hour protein in urine and Creatinine clearance. Complement 3and 4(C3,C4). Immunological investigations : Antinuclear antibody (ANA) and Anti-double stranded DNA (ds-DNA).

Serum CD147

Radiological investigations:

  • Chest X-ray
  • Renal Doppler
  • Multi-parametric MRI
systemic lupus erythematosus patients

Adult SLE Patients who fulfilled the 2019 EULAR / ACR classification criteria for systemic lupus erythematosus.

-SLE patients will be subjected to SLE Disease Activity Score (SLE-DAS).
Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147

Laboratory investigations:

erythrocyte sedimentation rate (ESR) Serum C-reactive protein (CRP) complete blood picture (CBC) liver function tests (LFT): aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin.

kidney function tests (KFT): serum creatinine and blood urea. Estimated glomerular filteration rate (eGFR) by CKD-EPI Creatinine Equation (2021).

Complete urine analysis for: proteinuria, urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field).

24 hour protein in urine and Creatinine clearance. Complement 3and 4(C3,C4). Immunological investigations : Antinuclear antibody (ANA) and Anti-double stranded DNA (ds-DNA).

Serum CD147

Radiological investigations:

  • Chest X-ray
  • Renal Doppler
  • Multi-parametric MRI
Healthy controls
Apparently healthy subjects
Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147

Laboratory investigations:

erythrocyte sedimentation rate (ESR) Serum C-reactive protein (CRP) complete blood picture (CBC) liver function tests (LFT): aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin.

kidney function tests (KFT): serum creatinine and blood urea. Estimated glomerular filteration rate (eGFR) by CKD-EPI Creatinine Equation (2021).

Complete urine analysis for: proteinuria, urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field).

24 hour protein in urine and Creatinine clearance. Complement 3and 4(C3,C4). Immunological investigations : Antinuclear antibody (ANA) and Anti-double stranded DNA (ds-DNA).

Serum CD147

Radiological investigations:

  • Chest X-ray
  • Renal Doppler
  • Multi-parametric MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate serum levels of CD147 in SSc and SLE patients
Time Frame: One year
Its correlation with renal impairment
One year
Evaluate renal resistive index in SSC and SLE patients
Time Frame: One year
It's correlation with renal impairment
One year
Evaluate Multiparametric MRI in SSC and SLE
Time Frame: One year
It's correlation with renal impairment
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of CD 147 in ssc and SLE patients
Time Frame: One year
for early detection of renal impairment inandSLE patients
One year
Utility of renal resistive index in SSC and SLE patients
Time Frame: One year
For early detection of renal impairment
One year
Utility of Multiparametric MRI in SSC and SLE
Time Frame: One year
For early detection of renal impairment
One year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Nihal Ahmed Fathi, Prof., Assiut University
  • Study Director: Marwa Mahmoud Abdelaziz, Prof., 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)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renal assess in SSc and SLE

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.

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