Systemic Sclerosis and Systemic Lupus ErythematousNCT06287125
Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients
An observational study of Systemic Sclerosis and Systemic Lupus Erythematous, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Sclerosis and Systemic Lupus Erythematous
- What is being tested?
- Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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].
- Adult SLE Patients who fulfilled the 2019 EULAR / ACR classification criteria for systemic lupus erythematosus [15]
Who cannot join
- Individuals with other autoimmune diseases.
- Smoking.
- Infections as chest infection, hepatitis C, hepatitis B and HIV infection.
- Tumors as hepatocellular carcinoma.
- Hypertension, diabetes, heart failure, hepatic diseases, chronic renal failure, intrarenal arteriovenous fistula, obstructive nephropathy and urinary tract obstruction.
- Contraindication for MRI as implanted metallic devices.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- 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.
Read the 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.
- Being tested
- Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147Device
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147 | |
| 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). Receives: Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147 | |
| Healthy controls | Apparently healthy subjects Receives: Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate serum levels of CD147 in SSc and SLE patients
Its correlation with renal impairment
Measured: One year
Evaluate renal resistive index in SSC and SLE patients
It's correlation with renal impairment
Measured: One year
Evaluate Multiparametric MRI in SSC and SLE
It's correlation with renal impairment
Measured: One year
Secondary outcomes (3)
Utility of CD 147 in ssc and SLE patients
for early detection of renal impairment inandSLE patients
Measured: One year
Utility of renal resistive index in SSC and SLE patients
For early detection of renal impairment
Measured: One year
Utility of Multiparametric MRI in SSC and SLE
For early detection of renal impairment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Systemic Sclerosis and Systemic Lupus ErythematousStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nabil Badr, Assiut University
- Investigators
- Nihal Ahmed Fathi, Prof., Study director, Assiut UniversityMarwa Mahmoud Abdelaziz, Prof., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287125
- Sponsor's protocol ID
- Renal assess in SSc and SLE
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29763902Zhao 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.
PubMed 33758813Gigante 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.
PubMed 31203218Pellicano 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.
PubMed 36436115Anders 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.
PubMed 24402709Muramatsu 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.
PubMed 22880881Yanaba 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.
PubMed 22298186Pistol 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.
PubMed 17488482Abd 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
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.
PubMed 28340199Francis 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.
PubMed 37187282Zhang 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.
PubMed 30659687van 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.
PubMed 24092682Preliminary 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.
PubMed 7378088Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.
PubMed 31385462
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT06287125
- Acronym / sponsor ID
- Renal assess in SSc and SLE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| systemic sclerosis patients | – | Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147Adult (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 |
| systemic lupus erythematosus patients | – | Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147Adult 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). |
| Healthy controls | – | Device: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147Apparently healthy subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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].
- Adult SLE Patients who fulfilled the 2019 EULAR / ACR classification criteria for systemic lupus erythematosus [15]
Key exclusion criteria (6 listed)
- Individuals with other autoimmune diseases.
- Smoking.
- Infections as chest infection, hepatitis C, hepatitis B and HIV infection.
- Tumors as hepatocellular carcinoma.
- Hypertension, diabetes, heart failure, hepatic diseases, chronic renal failure, intrarenal arteriovenous fistula, obstructive nephropathy and urinary tract obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147Laboratory 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 | Device | Healthy controls, systemic lupus erythematosus patients, systemic sclerosis patients |
Primary outcome
Evaluate serum levels of CD147 in SSc and SLE patients
Time frame: One year
Its correlation with renal impairment
Evaluate renal resistive index in SSC and SLE patients
Time frame: One year
It's correlation with renal impairment
Evaluate Multiparametric MRI in SSC and SLE
Time frame: One year
It's correlation with renal impairment
3 secondary outcomes
Utility of CD 147 in ssc and SLE patients
Time frame: One year
Utility of renal resistive index in SSC and SLE patients
Time frame: One year
Utility of Multiparametric MRI in SSC and SLE
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 29763902Rosato 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.
- Background: PubMed 33758813Zhao 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.
- Background: PubMed 31203218Gigante 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.
- Background: PubMed 36436115Pellicano 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.
- Background: PubMed 24402709Anders 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.
- Background: PubMed 22880881Muramatsu 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.
- Background: PubMed 22298186Yanaba 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.
- Background: PubMed 17488482Pistol 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.
- BackgroundAbd 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
- Background: PubMed 28340199Rosato 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.
- Background: PubMed 37187282Francis 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.
- Background: PubMed 30659687Zhang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nihal Ahmed Fathi, Prof. study director
Assiut University
Marwa Mahmoud Abdelaziz, Prof. study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Systemic Lupus Erythematous, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Nabil Badr, assistant lecturer (01007176797, asmaabadr347@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate serum levels of CD147 in SSc and SLE patients (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287125, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.