Prediction of Outcome of Lupus Nephritis
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Other: Serum collection
- Registration Number
- NCT02403115
- Lead Sponsor
- Istituto Giannina Gaslini
- Brief 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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Incident SLE without nephritis Serum collection 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. Lupus Nephritis Serum collection Collection of serum at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the dosage of circulating autoantibodies. Prevalent SLE without nephritis Serum collection 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. Membranous glomerulonephritis Serum collection 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. Rheumatoid arthritis Serum collection 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.
- Primary Outcome Measures
Name Time Method Change from baseline in Proteinuria at 12, 24 and 36 months 12, 24, 36 months proteinuria measured on a 24-hour urine collection.
- Secondary Outcome Measures
Name Time Method Renal function 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)
Trial Locations
- Locations (1)
IRCCS Giannina Gaslini Children Hospital
🇮🇹Genoa, Italy/GE, Italy