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Trial record 22 of 56 for:    Systemic Lupus Erythematosus with Nephritis 2

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

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ClinicalTrials.gov Identifier: NCT03664908
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment Phase
Lupus Nephritis Other: Detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method). Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN) Screening in Systemic Lupus Erythematosus (SLE) Patients?
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : March 1, 2019


Arm Intervention/treatment
Experimental: serum samples of SLE patients without LN
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).
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.

Experimental: serum samples of Lupus nephritis (LN) patients
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).
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.

Experimental: healthy voluntary blood donors (control group)
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).
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.




Primary Outcome Measures :
  1. Percentage of serum with anti GBM positivity [ Time Frame: Day 0 ]
    circulating antibody rates higher than 20 cu/mi using chemiluminescence


Secondary Outcome Measures :
  1. Description of clinical features of patients [ Time Frame: Day 0 ]
    as gender, ethnical group and mean age of patients

  2. Description of SLE characteristics [ Time Frame: Day 0 ]
    as age of disease onset, ACR criteria in patients with and without anti GBM positivity

  3. Description of immunological characteristics of patients with anti GBM positivity [ Time Frame: Day 0 ]
    presence of other auto immune disease, lupus anticoagulant, false positive syphilis test anticandidipid

  4. Description of renal characteristics of patient with anti GBM positivity [ Time Frame: Day 0 ]
    presence kidney disease or significant proteinurie or hemaluria or pyuria or urinary casts and kidney histology



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664908


Contacts
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Contact: Pauline ORQUEVAUX 03 26 83 24 65 porquevaux@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Pauline Orquevaux    03 26 83 24 65    porquevaux@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03664908     History of Changes
Other Study ID Numbers: PO18049
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:
Lupus nephritis
systemic lupus erythematosus
anti-glomerular basement membrane disease anti-GBM antiboby

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Nephritis
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Antibodies
Immunoglobulins
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs