Clinical trial NCT06287125: Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients
Official title: Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Systemic Sclerosis and Systemic Lupus Erythematous
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: * 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate serum levels of CD147 in SSc and SLE patients
timeFrame: One year
measure: Evaluate renal resistive index in SSC and SLE patients
timeFrame: One year
measure: Evaluate Multiparametric MRI in SSC and SLE
timeFrame: One year
Secondary outcomes:
measure: Utility of CD 147 in ssc and SLE patients
timeFrame: One year
measure: Utility of renal resistive index in SSC and SLE patients
timeFrame: One year
measure: Utility of Multiparametric MRI in SSC and SLE
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Nihal Ahmed Fathi, Prof.
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Marwa Mahmoud Abdelaziz, Prof.
role: STUDY_DIRECTOR
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