Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)?

NCT03664908 | Completed

• 1 other identifier: PO18049
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction and background : Glomerulonephritis and auto-immune diseases are often associated. Lupus nephritis (LN) is one of the major clinical manifestations of systemic lupus erythematosus (SLE) which have a severe impact on prognosis. This complication is a real challenge for clinicians because of insidious-onset and no predictable relapses. Biomarker use is therefore essential, but conventional biomarkers such as proteinuria have poor sensivity and low specificity to predict LN occurrence, and new more reliable biomarkers (genetic, epigenetic or protein biomarkers) are difficult to use for daily medical practice. Anti-glomerular membrane basement disease (anti-GBM disease) is a rare (0.5 to 1/millions of inhabitants) and severe illness, characterised by rapidly progressive glomerulonephritis, pulmonary haemorrhage and the presence of anti-GBM antibodies, which are highly sensible (100%) and specific (92-100%) of this condition . Our experience and literature review In our department of internal medicine, we report one case of anti-GBM glomerulonephritis associated to an active SLE. After literature review, we note the following studies:

• some similar association cases had been reported.
• In 2006, a Chinese cohort study highlighted important rates of anti-GBM antibodies, in serum samples from patients with SLE (14 positives/157patients (8.9%) using ELISA method). Moreover, every SLE patient with positive circulating anti-GMB antibodies LN and a severer SLE (with significantly more anemias, pulmonary hemorrhage). According to histological data's, they also had more important kidney damages (10/14 had necrotizing crescentic glomerulonephritis lesions and 5/14 fulfil criteria's for anti-GBM disease diagnosis).
• We also note that some authors published experimental studies showing that immunological and genetic links exist between LN and anti-GBM disease, which could explain this association. 3\. Main Hypothesis: Based on these findings, we suspect that detection of significant levels of circulating anti-GBM antibodies may be more frequent in SLE followed patients than in general population, and that it could be an interesting biomarker of LN in patient with SLE. 4\. Objectives First objective: based on 2 SLE patient groups (one having lupus nephritis and the other without it) we would like to compare the ratio of positive anti-GBM antibodies in each group, expecting a higher rate in SLE patients with LN. Second objective: will be to study the positive anti-GBM group patients in their clinical aspects, serological features and renal characteristics, in this SLE population. 5\. Materials and methods We suggest a retrospective analytic transversal controlled study, based on serum samples from the Lupus Biobank of Upper Rhine (LBBR project), and based on serum samples from healthy voluntary blood donors (control group). We will then perform tests in each serum sample group in our immunology laboratory and compare the ratio of positive anti-GBM in each arm.

Conditions

Lupus Nephritis

Keywords

Lupus nephritis; systemic lupus erythematosus; anti-glomerular basement membrane disease anti-GBM antiboby

Outcome Measures

Primary Outcomes (1)

• Percentage of serum with anti GBM positivity

  circulating antibody rates higher than 20 cu/mi using chemiluminescence

  Day 0

Secondary Outcomes (4)

• Description of clinical features of patients

  Day 0

• Description of SLE characteristics

  Day 0

• Description of immunological characteristics of patients with anti GBM positivity

  Day 0

• Description of renal characteristics of patient with anti GBM positivity

  Day 0

Study Arms (3)

serum samples of SLE patients without LN

EXPERIMENTAL

100 serum samples coming from systemic lupus erythematosus (SLE) patients without lupus nephritis (LN).

Other: Detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method).

serum samples of Lupus nephritis (LN) patients

EXPERIMENTAL

100 serum samples coming from systemic lupus erythematosus(SLE) patients with lupus nephritis (LN)

Other: Detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method).

healthy voluntary blood donors (control group)

EXPERIMENTAL

100 serum sample coming from 100 healthy voluntary blood donors (provided by Regional blood center of Reims). This arm will be our control group.

Other: Detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method).

Interventions

Detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method). OTHER

biological detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method) in three serum samples groups, coming from SLE patients (having Lupus Nephritis or not) and in a control group.

healthy voluntary blood donors (control group); serum samples of Lupus nephritis (LN) patients; serum samples of SLE patients without LN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• serum samples coming from LBBR lupus biobank (diagnosis of lupus according ACR criteria or diagnosis of lupus nephritis according to ISN/RPS2003) or serum sample coming from healthy bload donor volunters
• having signed the informed consent

You may not qualify if:

• diagnosis of lupus nephritis and having a beginning kidney disease (every class I and II of WHO classification and class I or II of ISN/RPS classification)
• lack of data regarding kidney histology on clinical LBBR file
• minor healthy blood donor
• healthy blood donor volunters with auto immune disease, or kidney disease, or chronic renal failure or taking immunosuppressive or immunomodulatory therapy or with history of cutaneous lupus or SLE

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

• Bourse Chalvon N, Orquevaux P, Giusti D, Gatouillat G, Tabary T, Tonye Libyh M, Chrusciel J, Drame M, Stockton-Bliard G, Amoura Z, Arnaud L, Lorenz HM, Blaison G, Bonnotte B, Magy-Bertrand N, Revuz S, Voll RE, Hinschberger O, Schwarting A, Pham BN, Martin T, Pennaforte JL, Servettaz A. Absence of Anti-Glomerular Basement Membrane Antibodies in 200 Patients With Systemic Lupus Erythematosus With or Without Lupus Nephritis: Results of the GOODLUPUS Study. Front Immunol. 2020 Dec 14;11:597863. doi: 10.3389/fimmu.2020.597863. eCollection 2020.

  PMID: 33381119 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

Fluorescent Antibody Technique, Indirect; Methods

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluorescent Antibody Technique; Immunohistochemistry; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: September 11, 2018
• Study Start: September 1, 2018
• Primary Completion: April 4, 2019
• Study Completion: May 4, 2019
• Last Updated: January 21, 2026

Record last verified: 2020-06

Locations

FR (1)