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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Istituto Giannina Gaslini · Academic / Other
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 .

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
OTHER	Serum collection	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

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-11-01
• Completion: 2022-11-01
• First posted: 2015-03-31
• Last updated: 2020-07-29

Locations

1 site across 1 country: Italy