Official Title
ANTI-SARS-CoV-2 SEROCONVERSIO IN IMMUNE-MEDIATED KIDNEY DISEASES
Brief Summary

This is a multicentric, observational, retrospective study. The primary endpoint of thestudy is to investigate the humoral immunological response to SARS-Cov-2 vaccination inthis population, looking for clinical features predisposing to seroconversion failure.Secondary endpoints are - to investigate the appearance of symptomatic SARS-CoV-2 infection, despite vaccination, looking for any clinical features predisposing to infection, - to identify the protective cut-off of antibody titer against SARS-CoV-2 infection.Each study participating center will select all vaccinated patients with immune-mediatedrenal diseases for whom anti-COVID serology will be available.

Detailed Description

SARS-CoV-2 infection produces a quantifiable immune response. Post-infection immunity
consists of a humoral and cell-mediated response, which appears to reduce the risk of
SARS-CoV-2 re-infection for at least 6 months in the healthy population. It is reasonable
to assume that SARS-COV-2 vaccination may also induce a similar response.

In immunomediated renal disease patients, it is not known what the antibody response is,
what factors can potentially influence it, other than immunosuppressive therapy. This
information, on the other hand, is useful not only in identifying individuals at risk of
infection despite vaccination but it can help to personalize the vaccination schedule.

All patients with immune-mediated renal diseases undergoing the complete vaccination
cycle (one or two doses depending on the type of vaccine used) against SARS-CoV-2, and
for whom at least one dosage of anti-SARS-CoV-2 antibodies are eligible.

After obtaining signed informed consent, personal data, underlying disease, biochemical
parameters (including immunoglobulin assay and lymphocyte typing, if available), present
or previous comorbidities, immunosuppressive therapies, dosage of SARS-CoV-2 IgG
antiSpike and/or antiRBD/Spike antibodies, the date of vaccinations and the type of
vaccine performed will be extracted.

The data are all present in the patients' inpatient and/or outpatient medical records, as
part of normal clinical management and completely independent of participation in the
current clinical trial.

The interview with the patient will show the possible appearance of COVID-19 infection,
the date of his diagnosis, confirmed by a positive molecular swab, the degree of severity
and the clinical course.

Completed
Immune-mediated Diseases
Glomerulonephritis
Eligibility Criteria

Inclusion Criteria:

- 1.Age ≥ 18 years 2. MRI diagnosis (biopsy and non-biopsy) 3. At least one complete
vaccination cycle according to the indications of the NHS (consisting of two doses
or a single dose depending on the type of vaccine) 4. Signing of informed consent 5.
At least one dose of anti-SARS-CoV2 IgG antibodies performed after a complete
vaccination course

Exclusion Criteria:

- SARS-CoV-2 infection, before or during the vaccination cycle (between I and II
dose), diagnosed by molecular swab or positivity to anti-Nucleocapsid antibodies or
anti-Spike IgM.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna 3181928, Italy

Fausta Catapano, MD, PhD, Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT Number
Keywords
immune-mediated kidney disease
Seroconversion
antiSARS Cov-2 vaccination
MeSH Terms
Glomerulonephritis
HIV Seropositivity