Clinical trial NCT02403115: Prediction of Outcome of Lupus Nephritis
Official title: Validation of the Assay of Circulating Antibodies Against Glomerular Neo-autoantigens as a Surrogate Biomarker of the Development of Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Istituto Giannina Gaslini
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 800
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 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).

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Proteinuria at 12, 24 and 36 months
timeFrame: 12, 24, 36 months
Secondary outcomes:
measure: Renal function
timeFrame: 36 months
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Giannina Gaslini Children Hospital
state: Italy/GE
Study officials:
affiliation: IRCCS Giannina Gaslini, Genoa
name: Gian Marco Ghiggeri, MD
role: STUDY_DIRECTOR
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