- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02403115
Prediction of Outcome of Lupus Nephritis
Validation of the Assay of Circulating Antibodies Against Glomerular Neo-autoantigens as a Surrogate Biomarker of the Development of Lupus Nephritis
The purpose of this study is to clarify the mechanisms involved in the formation and glomerular deposition of immune complexes in lupus nephritis.
The determination of an antibody pattern specific for systemic lupus erythematosus and lupus nephritis may also have a role in predicting disease progression in patients with systemic lupus erythematosus without renal impairment. As for the patients enrolled in the study, the determination of their antibody patterns may contribute to a more targeted and personalized treatment, allowing a prediction of disease progression and the introduction of early targeted treatments, in order to block the onset and/or progression of renal damage.
Přehled studie
Detailní popis
Prospective multicenter study on the validity of levels of circulating antibodies to glomerular neo-autoantigens (alpha-enolase and annexin AI) and implantable antigens (anti-DNA, histone, istone3, istone4, C1q) as a surrogate biomarker for the diagnosis of lupus nephritis.
The study will involve the collection of serum from patients with lupus nephritis at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the titration of circulating autoantibodies.
As a control the investigators will use the sera of patients with systemic lupus erythematosus without nephropathy, collected at the same time intervals.
The investigators will also assess the antibody positivity in groups of patients with rheumatologic disease similar to lupus (rheumatoid arthritis) and in patients with autoimmune nephropathy without extrarenal clinical signs.
Regarding patients with systemic lupus erythematosus the investigators will collect sera of both incident and prevalent patients in order to monitor changes in antibody levels in conjunction with the development of renal disease.
Clinical tests (renal function, complete blood count, C reactive protein (CRP), ANA, native DNA (nDNA), urine analysis) will be performed at 6, 12, 24 and 36 months and the surplus of blood samples will be used to create the serum bank of the study.
Samples will be collected in the pediatric nephrology of Giannina Gaslini Children Hospital, Genoa (coordinator centre) and in 5 rheumatological (Genoa, Pisa, Pavia, Padova, Brescia) and 6 nephrological (Milan, Genoa, Parma, Brescia, Bologna and Reggio Emilia) italian adults departments .
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Italy/GE
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Genoa, Italy/GE, Itálie, 16147
- Nábor
- IRCCS Giannina Gaslini Children Hospital
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Kontakt:
- Gian Marco Ghiggeri, MD
- Telefonní číslo: 0039 010 5636 2419
- E-mail: gmarcoghiggeri@ospedale-gaslini.ge.it
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Vrchní vyšetřovatel:
- Gian Marco Ghiggeri, MD
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Dílčí vyšetřovatel:
- Alice Bonanni, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
- 250 patients with newly diagnosed lupus nephritis (stage I-VI according to WHO classification). First serum will be collected at the time of renal biopsy (study group).
- 250 patients with incident or prevalent systemic lupus erythematosus (according to ARA criteria) and no signs of nephropathy (control group).
- 50 patients with rheumatoid arthritis (according to ARA criteria), without documented nephropathy (control group)
- 250 patients with histological diagnosis of membranous nephropathy (control group).
Popis
Inclusion Criteria:
- Age between 4 and 65 years
- Diagnosis of lupus nephritis-systemic lupus erythematosus (systemic lupus erythematosus, rheumatoid arthritis and membranous nephropathy for controls)
- Informed consent
Exclusion Criteria:
- Severe infections in place
- Malignancies of any current or history
- Chronic hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) positive
- Breast-feeding or pregnant
- Known hypersensitivity to drugs
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Lupus Nephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies.
|
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study
|
Incident SLE without nephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies, in order to evaluate the presence of nephritic manifestations.
|
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study
|
Prevalent SLE without nephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies in order to evaluate the presence of nephritic manifestations.
|
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study
|
Rheumatoid arthritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies in order to evaluate the presence of nephritic manifestations.
|
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study
|
Membranous glomerulonephritis
Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies in order to exclude secondary forms of the disease.
|
Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change from baseline in Proteinuria at 12, 24 and 36 months
Časové okno: 12, 24, 36 months
|
proteinuria measured on a 24-hour urine collection.
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12, 24, 36 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Renal function
Časové okno: 36 months
|
estimated glomerular filtration rate (eGFR) measured according to Revised Bedside Schwartz Formula (4-17 years old patients) or CKD-EPI Creatinine 2009 Equation (18-64 years old patients)
|
36 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Gian Marco Ghiggeri, MD, IRCCS Giannina Gaslini, Genoa
Publikace a užitečné odkazy
Obecné publikace
- Yu C, Gershwin ME, Chang C. Diagnostic criteria for systemic lupus erythematosus: a critical review. J Autoimmun. 2014 Feb-Mar;48-49:10-3. doi: 10.1016/j.jaut.2014.01.004. Epub 2014 Jan 21.
- Cameron JS. Lupus nephritis. J Am Soc Nephrol. 1999 Feb;10(2):413-24. doi: 10.1681/ASN.V102413. No abstract available.
- Madaio MP. The relevance of antigen binding to the pathogenicity of lupus autoantibodies. Kidney Int. 2012 Jul;82(2):125-7. doi: 10.1038/ki.2012.159.
- Waldman M, Madaio MP. Pathogenic autoantibodies in lupus nephritis. Lupus. 2005;14(1):19-24. doi: 10.1191/0961203305lu2054oa.
- Bagavant H, Fu SM. Pathogenesis of kidney disease in systemic lupus erythematosus. Curr Opin Rheumatol. 2009 Sep;21(5):489-94. doi: 10.1097/BOR.0b013e32832efff1.
- Hanrotel-Saliou C, Segalen I, Le Meur Y, Youinou P, Renaudineau Y. Glomerular antibodies in lupus nephritis. Clin Rev Allergy Immunol. 2011 Jun;40(3):151-8. doi: 10.1007/s12016-010-8204-4.
- Kramers C, Hylkema MN, van Bruggen MC, van de Lagemaat R, Dijkman HB, Assmann KJ, Smeenk RJ, Berden JH. Anti-nucleosome antibodies complexed to nucleosomal antigens show anti-DNA reactivity and bind to rat glomerular basement membrane in vivo. J Clin Invest. 1994 Aug;94(2):568-77. doi: 10.1172/JCI117371.
- Bruschi M, Galetti M, Sinico RA, Moroni G, Bonanni A, Radice A, Tincani A, Pratesi F, Migliorini P, Murtas C, Franceschini F, Trezzi B, Brunini F, Gatti R, Tardanico R, Barbano G, Piaggio G, Messa P, Ravani P, Scolari F, Candiano G, Martini A, Allegri L, Ghiggeri GM. Glomerular Autoimmune Multicomponents of Human Lupus Nephritis In Vivo (2): Planted Antigens. J Am Soc Nephrol. 2015 Aug;26(8):1905-24. doi: 10.1681/ASN.2014050493. Epub 2014 Nov 14.
- Bruschi M, Sinico RA, Moroni G, Pratesi F, Migliorini P, Galetti M, Murtas C, Tincani A, Madaio M, Radice A, Franceschini F, Trezzi B, Bianchi L, Giallongo A, Gatti R, Tardanico R, Scaloni A, D'Ambrosio C, Carnevali ML, Messa P, Ravani P, Barbano G, Bianco B, Bonanni A, Scolari F, Martini A, Candiano G, Allegri L, Ghiggeri GM. Glomerular autoimmune multicomponents of human lupus nephritis in vivo: alpha-enolase and annexin AI. J Am Soc Nephrol. 2014 Nov;25(11):2483-98. doi: 10.1681/ASN.2013090987. Epub 2014 May 1.
- Angeletti A, Bruschi M, Moroni G, Sinico RA, Franceschini F, Fredi M, Vaglio A, Cavagna L, Petretto A, Pratesi F, Migliorini P, Locatelli F, Pazzola G, Pesce G, Bagnasco M, Manfredi A, Ramirez GA, Esposito P, Murdaca G, Negrini S, Cipriani L, Trezzi B, Emmi G, Cavazzana I, Binda V, d'Alessandro M, Fenaroli P, Pisani I, Garibotto G, Montecucco C, Santoro D, Scolari F, Volpi S, Mosca M, Tincani A, Candiano G, Prunotto M, Verrina E, Ravelli A, Ghiggeri GM. Second Wave Antibodies in Autoimmune Renal Diseases: The Case of Lupus Nephritis. J Am Soc Nephrol. 2021 Dec 1;32(12):3020-3023. doi: 10.1681/ASN.2021050659. Epub 2021 Dec 1.
- Bruschi M, Moroni G, Sinico RA, Franceschini F, Fredi M, Vaglio A, Cavagna L, Petretto A, Pratesi F, Migliorini P, Manfredi A, Ramirez GA, Esposito P, Negrini S, Trezzi B, Emmi G, Santoro D, Scolari F, Volpi S, Mosca M, Tincani A, Candiano G, Prunotto M, Verrina E, Angeletti A, Ravelli A, Ghiggeri GM. Neutrophil Extracellular Traps in the Autoimmunity Context. Front Med (Lausanne). 2021 Mar 22;8:614829. doi: 10.3389/fmed.2021.614829. eCollection 2021.
- Bruschi M, Moroni G, Sinico RA, Franceschini F, Fredi M, Vaglio A, Cavagna L, Petretto A, Pratesi F, Migliorini P, Locatelli F, Pazzola G, Pesce G, Bagnasco M, Manfredi A, Ramirez GA, Esposito P, Murdaca G, Negrini S, Cipriani L, Trezzi B, Emmi G, Cavazzana I, Binda V, Fenaroli P, Pisani I, Garibotto G, Montecucco C, Santoro D, Scolari F, Mosca M, Tincani A, Candiano G, Prunotto M, Volpi S, Verrina E, Angeletti A, Ravelli A, Ghiggeri GM. Serum IgG2 antibody multicomposition in systemic lupus erythematosus and lupus nephritis (Part 1): cross-sectional analysis. Rheumatology (Oxford). 2021 Jul 1;60(7):3176-3188. doi: 10.1093/rheumatology/keaa767.
- Bruschi M, Moroni G, Sinico RA, Franceschini F, Fredi M, Vaglio A, Cavagna L, Petretto A, Pratesi F, Migliorini P, Locatelli F, Pazzola G, Pesce G, Bagnasco M, Manfredi A, Ramirez GA, Esposito P, Murdaca G, Negrini S, Cipriani L, Trezzi B, Emmi G, Cavazzana I, Binda V, d'Alessandro M, Fenaroli P, Pisani I, Garibotto G, Montecucco C, Santoro D, Scolari F, Volpi S, Mosca M, Tincani A, Candiano G, Prunotto M, Verrina E, Angeletti A, Ravelli A, Ghiggeri GM. Serum IgG2 antibody multi-composition in systemic lupus erythematosus and in lupus nephritis (Part 2): prospective study. Rheumatology (Oxford). 2021 Jul 1;60(7):3388-3397. doi: 10.1093/rheumatology/keaa793.
- Bruschi M, Bonanni A, Petretto A, Vaglio A, Pratesi F, Santucci L, Migliorini P, Bertelli R, Galetti M, Belletti S, Cavagna L, Moroni G, Franceschini F, Fredi M, Pazzola G, Allegri L, Sinico RA, Pesce G, Bagnasco M, Manfredi A, Ramirez GA, Ramoino P, Bianchini P, Puppo F, Pupo F, Negrini S, Mattana F, Emmi G, Garibotto G, Santoro D, Scolari F, Ravelli A, Tincani A, Cravedi P, Volpi S, Candiano G, Ghiggeri GM. Neutrophil Extracellular Traps Profiles in Patients with Incident Systemic Lupus Erythematosus and Lupus Nephritis. J Rheumatol. 2020 Mar;47(3):377-386. doi: 10.3899/jrheum.181232. Epub 2019 May 15.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SLE1
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