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

NCT ID: NCT06287125

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-03-01

Brief Summary

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* 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

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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.

Conditions

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Systemic Sclerosis and Systemic Lupus Erythematous

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147

Intervention Type DEVICE

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).

Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147

Intervention Type DEVICE

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

Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nabil Badr

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nihal Ahmed Fathi, Prof.

Role: STUDY_DIRECTOR

Assiut University

Marwa Mahmoud Abdelaziz, Prof.

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Asmaa Nabil Badr, assistant lecturer

Role: CONTACT

Phone: 01007176797

Email: [email protected]

Esraa Ahmed Talat, lecturer

Role: CONTACT

Phone: 01003314717

Email: [email protected]

References

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Rosato E, Gigante A, Barbano B, Gasperini ML, Cianci R, Muscaritoli M. Prognostic Factors of Renal Involvement in Systemic Sclerosis. Kidney Blood Press Res. 2018;43(3):682-689. doi: 10.1159/000489740. Epub 2018 May 10.

Reference Type BACKGROUND
PMID: 29763902 (View on PubMed)

Zhao T, Lin FA, Chen HP. Pattern of Nailfold Capillaroscopy in Patients With Systemic Lupus Erythematosus. Arch Rheumatol. 2020 Apr 20;35(4):568-574. doi: 10.46497/ArchRheumatol.2020.7763. eCollection 2020 Dec.

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PMID: 33758813 (View on PubMed)

Gigante A, Barbano B, Gasperini ML, Zingaretti V, Cianci R, Rosato E. Renal Parenchymal Thickness in Patients with Systemic Sclerosis Is Related to Intrarenal Hemodynamic Variables and Raynaud Renal Phenomenon. J Rheumatol. 2020 Apr;47(4):567-571. doi: 10.3899/jrheum.190165. Epub 2019 Jun 15.

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PMID: 31203218 (View on PubMed)

Pellicano C, Vaiarello V, Colalillo A, Gigante A, Iannazzo F, Rosato E. Role of kinurenic acid in the systemic sclerosis renal involvement. Clin Exp Med. 2023 Sep;23(5):1713-1719. doi: 10.1007/s10238-022-00962-6. Epub 2022 Nov 27.

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Anders HJ, Fogo AB. Immunopathology of lupus nephritis. Semin Immunopathol. 2014 Jul;36(4):443-59. doi: 10.1007/s00281-013-0413-5. Epub 2014 Jan 9.

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Muramatsu T. Basigin: a multifunctional membrane protein with an emerging role in infections by malaria parasites. Expert Opin Ther Targets. 2012 Oct;16(10):999-1011. doi: 10.1517/14728222.2012.711818. Epub 2012 Aug 11.

Reference Type BACKGROUND
PMID: 22880881 (View on PubMed)

Yanaba K, Asano Y, Tada Y, Sugaya M, Kadono T, Hamaguchi Y, Sato S. Increased serum soluble CD147 levels in patients with systemic sclerosis: association with scleroderma renal crisis. Clin Rheumatol. 2012 May;31(5):835-9. doi: 10.1007/s10067-012-1949-9.

Reference Type BACKGROUND
PMID: 22298186 (View on PubMed)

Pistol G, Matache C, Calugaru A, Stavaru C, Tanaseanu S, Ionescu R, Dumitrache S, Stefanescu M. Roles of CD147 on T lymphocytes activation and MMP-9 secretion in systemic lupus erythematosus. J Cell Mol Med. 2007 Mar-Apr;11(2):339-48. doi: 10.1111/j.1582-4934.2007.00022.x.

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PMID: 17488482 (View on PubMed)

Abd Elsamea MH, Badr AN, Talaat EARenal, et al. Arterial resistive index as a noninvasive biomarker of disease activity in lupus nephritis patients. Egypt Rheumatologist 2022; 44(3):239-244

Reference Type BACKGROUND

Rosato E, Navarini L, Gigante A, Cianci R, Margiotta D, Barbano B, Afeltra A. Intrarenal arterial stiffness is increased in systemic sclerosis patients with anti-ribonucleic acid polymerase III antibodies. Rheumatology (Oxford). 2017 Jun 1;56(6):1039-1041. doi: 10.1093/rheumatology/kex051. No abstract available.

Reference Type BACKGROUND
PMID: 28340199 (View on PubMed)

Francis ST, Selby NM, Taal MW. Magnetic Resonance Imaging to Evaluate Kidney Structure, Function, and Pathology: Moving Toward Clinical Application. Am J Kidney Dis. 2023 Oct;82(4):491-504. doi: 10.1053/j.ajkd.2023.02.007. Epub 2023 May 13.

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PMID: 37187282 (View on PubMed)

Zhang S, Lin Y, Ge X, Liu G, Zhang J, Xu S, Wu G, Chen S, Xu J, Suo S. Multiparameter diffusion-weighted imaging for characterizing pathological patterns in lupus nephritis patients: A preliminary study. J Magn Reson Imaging. 2019 Oct;50(4):1075-1084. doi: 10.1002/jmri.26657. Epub 2019 Jan 18.

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van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Muller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Ellen Csuka M, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Ann Rheum Dis. 2013 Nov;72(11):1747-55. doi: 10.1136/annrheumdis-2013-204424.

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Preliminary criteria for the classification of systemic sclerosis (scleroderma). Subcommittee for scleroderma criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee. Arthritis Rheum. 1980 May;23(5):581-90. doi: 10.1002/art.1780230510.

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Other Identifiers

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Renal assess in SSc and SLE

Identifier Type: -

Identifier Source: org_study_id