Systemic Lupus Erythematosus NephritisIgFicoLupusNCT03842787
Anti-ficolin-3 Antibodies in Lupus Nephritis
An observational study of Systemic Lupus Erythematosus Nephritis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus Nephritis
- What is being tested?
- Biological analysis
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2019to 20 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SLE patients with lupus Nephritis
Who may be able to join
- Age ≥ 18 years old
- Patients who have valid health insurance
- Non-opposition to participation obtained
- Diagnostic de lupus according to SLICC 2012, performed more than 3 months ago.
- Active lupus nephritis defined by :
- elevated SLEDAI indexes (≥ 4), the presence of a significant proteinuria (≥ 0.5 g/day) and/or the presence of hematuria, aseptic leukocyturia or urinary casts, and documented by renal biopsy and classified according to the ISN/RPS classification.
Show all 13Show fewer
- Non-inclusion Criteria:
- Patient with a known progressing cancer
- Patient who had started lupus nephritis flare treatment
- Participant involved in another interventional clinical study
- Person deprived of liberty by judicial order
- Person under guardianship or curatorship
- Hemoglobin level < 7 g/dL
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Anti-ficolin-3 Antibodies in the Pathogenesis of Lupus Nephritis
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage. Although the underlying mechanisms are complex, defects in dying cells elimination are likely to contribute to autoantigen overload and development of autoimmunity. Molecules important in damaged cell clearance, such as early complement components, may thus have a protective role. According to this hypothesis, deficiencies in C1q and MBL, the recognition proteins of the classical and lectin pathways of complement; are associated with increased susceptibility to SLE. In the proposed project, the investigators will investigate the involvement of another related recognition protein, ficolin-3, which activates the complement lectin pathway and recognizes necrotic cells. The investigators have shown in a recent study a significant association between the presence of anti-ficolin-3 antibodies and active nephritis in patients with SLE. However, the possible involvement of anti-ficolin-3 antibodies in the pathogenesis of SLE and particularly in lupus nephritis (LN) remains to be elucidated. This project plans to investigate the role of ficolin-3 and ficolin-3 autoantibodies in LN. The study associates two aspects, aiming at deciphering the role of anti-ficolin-3 antibodies in dying cells recognition and investigating the role of ficolin-3 in renal tissue damage. This pilot study will be performed for 14 patients with active LN on serum and renal biopsy, realized for routine patient care. The investigators will explore the effect of anti-ficolin-3 antibodies purified from the patient serum on ficolin-3-dependent necrotic cells recognition, in relation with possible altered clearance of dead cells, which is an important hypothesis of the pathogenesis of SLE. The investigators will also investigate ficolin-3 deposition in renal biopsy, which may contribute to the local formation of immune complexes, leading to complement activation and subsequent inflammation and tissue injury.
Read the detailed description
PRIMARY OUTCOME MEASURE Exploration of the inhibition of anti-ficolin-3 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-3-dependent necrotic cells recognition.
The criterion used is the shift of MFI (Mean Fluorescence Intensity) measured after addition of these antibodies to necrotic Jurkat cells incubated with ficolin-3.
The study has a single visit approach with serum collection, so every outcome is measured at T0, which is the only visit for the patient.
SECONDARY OUTCOME MEASURES
- Investigation of ficolin-3 deposition in renal biopsy of the same 14 patients with active LN. Analysis: deposition of ficolin-3 will be evaluated by immunostaining on renal biopsy.
- Quantification of anti-ficolin-3 antibodies. Analysis: Anti-ficolin-3 antibodies are quantified by ELISA.
- Quantification of serum levels of ficolin-3. Analysis: Ficolin-3 is quantified by ELISA.
- Correlation between anti-ficolin-3 antibodies and serum levels of ficolin-3. Analysis: Anti-ficolin-3 antibodies and ficolin-3 are quantified by ELISA.
- Correlation between serum levels of anti-ficolin-3 antibodies and ficolin-3 deposition in the kidney.
- Correlation between serum levels of ficolin-3 and ficolin-3 deposition in the kidney.
- Exploration of the inhibition of anti-ficolin-2 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-2-dependent necrotic cells recognition. The criterion used is the shift of MFI (Mean Fluorescence Intensity) measured after addition of these antibodies to necrotic Jurkat cells incubated with ficolin-2.
- Investigation of ficolin-2 deposition in renal biopsy of the same 14 patients with active LN. Analysis: deposition of ficolin-2 will be evaluated by immunostaining on renal biopsy.
- Quantification of anti-ficolin-2 antibodies. Analysis: Anti-ficolin-2 antibodies are quantified by ELISA.
- Quantification of serum levels of ficolin-2. Analysis: Ficolin-2 is quantified by ELISA.
- Correlation between anti-ficolin-2 antibodies and serum levels of ficolin-2. Analysis: Anti-ficolin-2 antibodies and ficolin-2 are quantified by ELISA.
- Correlation between serum levels of anti-ficolin-2 antibodies and ficolin-2 deposition in the kidney.
- Correlation between serum levels of ficolin-2 and ficolin-2 deposition in the kidney.
- Conditions
- Systemic Lupus Erythematosus Nephritis
- Being tested
- Biological analysis
- Keywords
- systemic lupus erythematosus, lupus nephritis, complement, ficolin-3, anti-ficolin-3 autoantibodies
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological analysisOther
Biological and research analysis:
Quantification of ficolin-3, anti-ficolin-3 antibodies, ficolin-2, anti-ficolin-2 antibodies
Purification of patients' antibodies (anti-ficolin-3 and -2)
Evaluation of effects of anti-ficolin-3 and anti-ficolin-2 purified antibodies Investigation of ficolin-3 and ficolin-2 deposition in renal biopsy
| Study group | Role | What they receive |
|---|---|---|
| SLE patients with lupus Nephritis | 14 SLE patients with lupus Nephritis
Biological analysis and biopsy were (routinely) performed
Ethics The protocol will be submitted to a randomly chosen Institutional Review Board (Comité de Protection des Personnes), in compliance to French regulation.
Investigators will include patients followed for routine care. Patients will be informed that samples (serum and kidney biopsy) that are performed for routine patient care will subsequently be used for research purposes, with no additional blood draw/biopsy. They will sign informed consent. Receives: Other: Biological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploration of the inhibition of anti-ficolin-3 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-3-dependent necrotic cells recognition.
In order to investigate the possible interference of the anti-ficolin-3 antibodies purified from patients'sera with ficolin-3 dependent necrotic cells recognition, recombinant ficolin-3 will be preincubated with the purified specific autoantibodies before addition to Jurkat necrotic cells. Ficolin-3 binding will be measured using the flow cytometry and immunofluorescence assays described above and quantified using the mean fluorescence intensity (MFI). The criterion used is the shift of MFI (Mean Fluorescence Intensity) measured after addition of these antibodies to necrotic Jurkat cells incubated with ficolin-3.
Measured: Measure at day of inclusion = TO
Secondary outcomes (13)
Investigation of ficolin-3 deposition in renal biopsy of the same 14 patients with active LN.
The investigators will investigate the presence of ficolin-3 in the glomeruli by direct immunofluorescence analysis. They search deposits in the interstitial vessels, interstitium and glomeruli (mesangium, extra-membranous, glomerular basement membrane) and quantify them semi-quantitatively (+, ++ or +++).
Measured: Measure at day of inclusion = TO
Quantification of anti-ficolin-3 antibodies.
Anti-ficolin-3 antibodies are quantified by ELISA. Results are given in Arbitrary Units (AU)
Measured: Measure at day of inclusion = TO
Quantification of serum levels of ficolin-3.
Ficolin-3 is quantified by ELISA. Results are given in µg/mL.
Measured: Measure at day of inclusion = TO
Correlation of anti-ficolin-3 antibodies and serum levels of ficolin-3.
Anti-ficolin-3 antibodies and ficolin-3 are quantified by ELISA.
Measured: Measure at day of inclusion = TO
Correlation between serum levels of anti-ficolin-3 antibodies and ficolin-3 deposition in the kidney.
Serum levels of anti-ficolin-3 antibodies and ficolin-3 deposition in the kidney are quantified by ELISA.
Measured: Measure at day of inclusion = TO
Correlation between serum levels of ficolin-3 and ficolin-3 deposition in the kidney.
Serum levels of ficolin-3 and ficolin-3 deposition in the kidney are quantified by ELISA.
Measured: Measure at day of inclusion = TO
Exploration of the inhibition of anti-ficolin-2 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-2-dependent necrotic cells recognition.
In order to investigate the possible interference of the anti-ficolin-2 antibodies purified from patients'sera with ficolin-2 dependent necrotic cells recognition, recombinant ficolin-2 will be preincubated with the purified specific autoantibodies before addition to Jurkat necrotic cells. Ficolin-2 binding will be measured using the flow cytometry and immunofluorescence assays described above and quantified using the mean fluorescence intensity (MFI). The criterion used is the shift of MFI (Mean Fluorescence Intensity) measured after addition of these antibodies to necrotic Jurkat cells incubated with ficolin-2.
Measured: Measure at day of inclusion = TO
Investigation of ficolin-2 deposition in renal biopsy of the same 14 patients with active LN.
The investigators will investigate the presence of ficolin-2 in the glomeruli by direct immunofluorescence analysis. They search deposits in the interstitial vessels, interstitium and glomeruli (mesangium, extra-membranous, glomerular basement membrane) and quantify them semi-quantitatively (+, ++ or +++).
Measured: Measure at day of inclusion = TO
Quantification of anti-ficolin-2 antibodies.
Anti-ficolin-2 antibodies are quantified by ELISA. Results are given in arbitrary units (AU).
Measured: Measure at day of inclusion = TO
Quantification of serum levels of ficolin-2.
Ficolin-2 is quantified by ELISA. Results are given in µg/mL.
Measured: Measure at day of inclusion = TO
Correlation between anti-ficolin-2 antibodies and serum levels of ficolin-2.
Anti-ficolin-2 antibodies and ficolin-2 are quantified by ELISA.
Measured: Measure at day of inclusion = TO
Correlation between serum levels of anti-ficolin-2 antibodies and ficolin-2 deposition in the kidney.
Serum levels of anti-ficolin-2 antibodies and ficolin-2 deposition in the kidney are quantified by ELISA.
Measured: Measure at day of inclusion = TO
Correlation between serum levels of ficolin-2 and ficolin-2 deposition in the kidney.
Serum levels of ficolin-2 and ficolin-2 deposition in the kidney are quantified by ELISA.
Measured: Measure at day of inclusion = TO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start7 Mar 2019
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus NephritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Biologie Structurale Grenoble
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842787
- Sponsor's protocol ID
- 38RC18.303
- Other IDs
- 2018-A02942-53
- Acronym
- IgFicoLupus
- Status last verified
- Sep 2021
- First submitted
- 22 Jan 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dumestre-Perard C, Clavarino G, Colliard S, Cesbron JY, Thielens NM. Antibodies targeting circulating protective molecules in lupus nephritis: Interest as serological biomarkers. Autoimmun Rev. 2018 Sep;17(9):890-899. doi: 10.1016/j.autrev.2018.03.013. Epub 2018 Jul 29.
PubMed 30009962Munoz LE, Lauber K, Schiller M, Manfredi AA, Schett G, Voll RE, Herrmann M. [The role of incomplete clearance of apoptotic cells in the etiology and pathogenesis of SLE]. Z Rheumatol. 2010 Mar;69(2):152, 154-6. doi: 10.1007/s00393-009-0603-7. German.
PubMed 20107814Kravitz MS, Shoenfeld Y. Autoimmunity to protective molecules: is it the perpetuum mobile (vicious cycle) of autoimmune rheumatic diseases? Nat Clin Pract Rheumatol. 2006 Sep;2(9):481-90. doi: 10.1038/ncprheum0290.
PubMed 16951703Herrmann M, Voll RE, Zoller OM, Hagenhofer M, Ponner BB, Kalden JR. Impaired phagocytosis of apoptotic cell material by monocyte-derived macrophages from patients with systemic lupus erythematosus. Arthritis Rheum. 1998 Jul;41(7):1241-50. doi: 10.1002/1529-0131(199807)41:73.0.CO;2-H.
PubMed 9663482Honore C, Hummelshoj T, Hansen BE, Madsen HO, Eggleton P, Garred P. The innate immune component ficolin 3 (Hakata antigen) mediates the clearance of late apoptotic cells. Arthritis Rheum. 2007 May;56(5):1598-607. doi: 10.1002/art.22564.
PubMed 17469142Liphaus BL, Kiss MH. The role of apoptosis proteins and complement components in the etiopathogenesis of systemic lupus erythematosus. Clinics (Sao Paulo). 2010 Mar;65(3):327-33. doi: 10.1590/S1807-59322010000300014.
PubMed 20360925Sato N, Ohsawa I, Nagamachi S, Ishii M, Kusaba G, Inoshita H, Toki A, Horikoshi S, Ohi H, Matsushita M, Tomino Y. Significance of glomerular activation of the alternative pathway and lectin pathway in lupus nephritis. Lupus. 2011 Nov;20(13):1378-86. doi: 10.1177/0961203311415561. Epub 2011 Sep 5.
PubMed 21893562Kuraya M, Ming Z, Liu X, Matsushita M, Fujita T. Specific binding of L-ficolin and H-ficolin to apoptotic cells leads to complement activation. Immunobiology. 2005;209(9):689-97. doi: 10.1016/j.imbio.2004.11.001.
PubMed 15804047Nisihara RM, Magrini F, Mocelin V, Messias-Reason IJ. Deposition of the lectin pathway of complement in renal biopsies of lupus nephritis patients. Hum Immunol. 2013 Aug;74(8):907-10. doi: 10.1016/j.humimm.2013.04.030. Epub 2013 Apr 29.
PubMed 23639552Tanha N, Pilely K, Faurschou M, Garred P, Jacobsen S. Plasma ficolin levels and risk of nephritis in Danish patients with systemic lupus erythematosus. Clin Rheumatol. 2017 Feb;36(2):335-341. doi: 10.1007/s10067-016-3508-2. Epub 2016 Dec 15.
PubMed 27981461Colliard S, Jourde-Chiche N, Clavarino G, Sarrot-Reynauld F, Gout E, Deroux A, Fougere M, Bardin N, Bouillet L, Cesbron JY, Thielens NM, Dumestre-Perard C. Autoantibodies Targeting Ficolin-2 in Systemic Lupus Erythematosus Patients With Active Nephritis. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1263-1268. doi: 10.1002/acr.23449. Epub 2018 Jun 21.
PubMed 29045037Plawecki M, Lheritier E, Clavarino G, Jourde-Chiche N, Ouili S, Paul S, Gout E, Sarrot-Reynauld F, Bardin N, Boelle PY, Chiche L, Bouillet L, Thielens NM, Cesbron JY, Dumestre-Perard C. Association between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients with Systemic Lupus Erythematosus. PLoS One. 2016 Sep 15;11(9):e0160879. doi: 10.1371/journal.pone.0160879. eCollection 2016.
PubMed 27631981Trouw LA, Daha MR. Role of anti-C1q autoantibodies in the pathogenesis of lupus nephritis. Expert Opin Biol Ther. 2005 Feb;5(2):243-51. doi: 10.1517/14712598.5.2.243.
PubMed 15757386
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anti-ficolin-3 Antibodies in the Pathogenesis of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT03842787
- Acronym / sponsor ID
- IgFicoLupus / 38RC18.303
- Conditions
- Systemic Lupus Erythematosus Nephritis
- Keywords
- systemic lupus erythematosus, lupus nephritis, complement, ficolin-3, anti-ficolin-3 autoantibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut de Biologie Structurale Grenoble
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage. Although the underlying mechanisms are complex, defects in dying cells elimination are likely to contribute to autoantigen overload and development of autoimmunity. Molecules important in damaged cell clearance, such as early complement components, may thus have a protective role. According to this hypothesis, deficiencies in C1q and MBL, the recognition proteins of the classical and lectin pathways of complement; are associated with increased susceptibility to SLE. In the proposed project, the investigators will investigate the involvement of another related recognition protein, ficolin-3, which activates the complement lectin pathway and recognizes necrotic cells. The investigators have shown in a recent study a significant association between the presence of anti-ficolin-3 antibodies and active nephritis in patients with SLE. However, the possible involvement of anti-ficolin-3 antibodies in the pathogenesis of SLE and particularly in lupus nephritis (LN) remains to be elucidated. This project plans to investigate the role of ficolin-3 and ficolin-3 autoantibodies in LN. The study associates two aspects, aiming at deciphering the role of anti-ficolin-3 antibodies in dying cells recognition and investigating the role of ficolin-3 in renal tissue damage. This pilot study will be performed for 14 patients with active LN on serum and renal biopsy, realized for routine patient care. The investigators will explore the effect of anti-ficolin-3 antibodies purified from the patient serum on ficolin-3-dependent necrotic cells recognition, in relation with possible altered clearance of dead cells, which is an important hypothesis of the pathogenesis of SLE. The investigators will also investigate ficolin-3 deposition in renal biopsy, which may contribute to the local formation of immune complexes, leading to complement activation and subsequent inflammation and tissue injury.
Detailed description
PRIMARY OUTCOME MEASURE Exploration of the inhibition of anti-ficolin-3 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-3-dependent necrotic cells recognition.
The criterion used is the shift of MFI (Mean Fluorescence Intensity) measured after addition of these antibodies to necrotic Jurkat cells incubated with ficolin-3.
The study has a single visit approach with serum collection, so every outcome is measured at T0, which is the only visit for the patient.
SECONDARY OUTCOME MEASURES
- Investigation of ficolin-3 deposition in renal biopsy of the same 14 patients with active LN. Analysis: deposition of ficolin-3 will be evaluated by immunostaining on renal biopsy.
- Quantification of anti-ficolin-3 antibodies. Analysis: Anti-ficolin-3 antibodies are quantified by ELISA.
- Quantification of serum levels of ficolin-3. Analysis: Ficolin-3 is quantified by ELISA.
- Correlation between anti-ficolin-3 antibodies and serum levels of ficolin-3. Analysis: Anti-ficolin-3 antibodies and ficolin-3 are quantified by ELISA.
- Correlation between serum levels of anti-ficolin-3 antibodies and ficolin-3 deposition in the kidney.
- Correlation between serum levels of ficolin-3 and ficolin-3 deposition in the kidney.
- Exploration of the inhibition of anti-ficolin-2 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-2-dependent necrotic cells recognition. The criterion used is the shift of MFI (Mean Fluorescence Intensity) measured after addition of these antibodies to necrotic Jurkat cells incubated with ficolin-2.
- Investigation of ficolin-2 deposition in renal biopsy of the same 14 patients with active LN. Analysis: deposition of ficolin-2 will be evaluated by immunostaining on renal biopsy.
- Quantification of anti-ficolin-2 antibodies. Analysis: Anti-ficolin-2 antibodies are quantified by ELISA.
- Quantification of serum levels of ficolin-2. Analysis: Ficolin-2 is quantified by ELISA.
- Correlation between anti-ficolin-2 antibodies and serum levels of ficolin-2. Analysis: Anti-ficolin-2 antibodies and ficolin-2 are quantified by ELISA.
- Correlation between serum levels of anti-ficolin-2 antibodies and ficolin-2 deposition in the kidney.
- Correlation between serum levels of ficolin-2 and ficolin-2 deposition in the kidney.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLE patients with lupus Nephritis | – | Other: Biological analysis14 SLE patients with lupus Nephritis Biological analysis and biopsy were (routinely) performed Ethics The protocol will be submitted to a randomly chosen Institutional Review Board (Comité de Protection des Personnes), in compliance to French regulation. Investigators will include patients followed for routine care. Patients will be informed that samples (serum and kidney biopsy) that are performed for routine patient care will subsequently be used for research purposes, with no additional blood draw/biopsy. They will sign informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SLE patients with lupus Nephritis
Key inclusion criteria (13 listed)
- Age ≥ 18 years old
- Patients who have valid health insurance
- Non-opposition to participation obtained
- Diagnostic de lupus according to SLICC 2012, performed more than 3 months ago.
- Active lupus nephritis defined by :
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological analysisBiological and research analysis: Quantification of ficolin-3, anti-ficolin-3 antibodies, ficolin-2, anti-ficolin-2 antibodies Purification of patients' antibodies (anti-ficolin-3 and -2) Evaluation of effects of anti-ficolin-3 and anti-ficolin-2 purified antibodies Investigation of ficolin-3 and ficolin-2 deposition in renal biopsy | Other | SLE patients with lupus Nephritis |
Primary outcome
Exploration of the inhibition of anti-ficolin-3 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-3-dependent necrotic cells recognition.
Time frame: Measure at day of inclusion = TO
In order to investigate the possible interference of the anti-ficolin-3 antibodies purified from patients'sera with ficolin-3 dependent necrotic cells recognition, recombinant ficolin-3 will be preincubated with the purified specific autoantibodies before addition to Jurkat necrotic cells. Ficolin-3 binding will be measured using the flow cytometry and immunofluorescence assays described above and quantified using the mean fluorescence intensity (MFI). The criterion used is the shift of MFI (Mean Fluorescence Intensity) measured after addition of these antibodies to necrotic Jurkat cells incubated with ficolin-3.
13 secondary outcomes
Investigation of ficolin-3 deposition in renal biopsy of the same 14 patients with active LN.
Time frame: Measure at day of inclusion = TO
Quantification of anti-ficolin-3 antibodies.
Time frame: Measure at day of inclusion = TO
Quantification of serum levels of ficolin-3.
Time frame: Measure at day of inclusion = TO
Correlation of anti-ficolin-3 antibodies and serum levels of ficolin-3.
Time frame: Measure at day of inclusion = TO
Correlation between serum levels of anti-ficolin-3 antibodies and ficolin-3 deposition in the kidney.
Time frame: Measure at day of inclusion = TO
Correlation between serum levels of ficolin-3 and ficolin-3 deposition in the kidney.
Time frame: Measure at day of inclusion = TO
Exploration of the inhibition of anti-ficolin-2 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-2-dependent necrotic cells recognition.
Time frame: Measure at day of inclusion = TO
Investigation of ficolin-2 deposition in renal biopsy of the same 14 patients with active LN.
Time frame: Measure at day of inclusion = TO
Quantification of anti-ficolin-2 antibodies.
Time frame: Measure at day of inclusion = TO
Quantification of serum levels of ficolin-2.
Time frame: Measure at day of inclusion = TO
Correlation between anti-ficolin-2 antibodies and serum levels of ficolin-2.
Time frame: Measure at day of inclusion = TO
Correlation between serum levels of anti-ficolin-2 antibodies and ficolin-2 deposition in the kidney.
Time frame: Measure at day of inclusion = TO
Correlation between serum levels of ficolin-2 and ficolin-2 deposition in the kidney.
Time frame: Measure at day of inclusion = TO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 30009962Dumestre-Perard C, Clavarino G, Colliard S, Cesbron JY, Thielens NM. Antibodies targeting circulating protective molecules in lupus nephritis: Interest as serological biomarkers. Autoimmun Rev. 2018 Sep;17(9):890-899. doi: 10.1016/j.autrev.2018.03.013. Epub 2018 Jul 29.
- Background: PubMed 20107814Munoz LE, Lauber K, Schiller M, Manfredi AA, Schett G, Voll RE, Herrmann M. [The role of incomplete clearance of apoptotic cells in the etiology and pathogenesis of SLE]. Z Rheumatol. 2010 Mar;69(2):152, 154-6. doi: 10.1007/s00393-009-0603-7. German.
- Background: PubMed 16951703Kravitz MS, Shoenfeld Y. Autoimmunity to protective molecules: is it the perpetuum mobile (vicious cycle) of autoimmune rheumatic diseases? Nat Clin Pract Rheumatol. 2006 Sep;2(9):481-90. doi: 10.1038/ncprheum0290.
- Background: PubMed 9663482Herrmann M, Voll RE, Zoller OM, Hagenhofer M, Ponner BB, Kalden JR. Impaired phagocytosis of apoptotic cell material by monocyte-derived macrophages from patients with systemic lupus erythematosus. Arthritis Rheum. 1998 Jul;41(7):1241-50. doi: 10.1002/1529-0131(199807)41:73.0.CO;2-H.
- Background: PubMed 17469142Honore C, Hummelshoj T, Hansen BE, Madsen HO, Eggleton P, Garred P. The innate immune component ficolin 3 (Hakata antigen) mediates the clearance of late apoptotic cells. Arthritis Rheum. 2007 May;56(5):1598-607. doi: 10.1002/art.22564.
- Background: PubMed 20360925Liphaus BL, Kiss MH. The role of apoptosis proteins and complement components in the etiopathogenesis of systemic lupus erythematosus. Clinics (Sao Paulo). 2010 Mar;65(3):327-33. doi: 10.1590/S1807-59322010000300014.
- Background: PubMed 21893562Sato N, Ohsawa I, Nagamachi S, Ishii M, Kusaba G, Inoshita H, Toki A, Horikoshi S, Ohi H, Matsushita M, Tomino Y. Significance of glomerular activation of the alternative pathway and lectin pathway in lupus nephritis. Lupus. 2011 Nov;20(13):1378-86. doi: 10.1177/0961203311415561. Epub 2011 Sep 5.
- Background: PubMed 15804047Kuraya M, Ming Z, Liu X, Matsushita M, Fujita T. Specific binding of L-ficolin and H-ficolin to apoptotic cells leads to complement activation. Immunobiology. 2005;209(9):689-97. doi: 10.1016/j.imbio.2004.11.001.
- Background: PubMed 23639552Nisihara RM, Magrini F, Mocelin V, Messias-Reason IJ. Deposition of the lectin pathway of complement in renal biopsies of lupus nephritis patients. Hum Immunol. 2013 Aug;74(8):907-10. doi: 10.1016/j.humimm.2013.04.030. Epub 2013 Apr 29.
- Background: PubMed 27981461Tanha N, Pilely K, Faurschou M, Garred P, Jacobsen S. Plasma ficolin levels and risk of nephritis in Danish patients with systemic lupus erythematosus. Clin Rheumatol. 2017 Feb;36(2):335-341. doi: 10.1007/s10067-016-3508-2. Epub 2016 Dec 15.
- Background: PubMed 29045037Colliard S, Jourde-Chiche N, Clavarino G, Sarrot-Reynauld F, Gout E, Deroux A, Fougere M, Bardin N, Bouillet L, Cesbron JY, Thielens NM, Dumestre-Perard C. Autoantibodies Targeting Ficolin-2 in Systemic Lupus Erythematosus Patients With Active Nephritis. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1263-1268. doi: 10.1002/acr.23449. Epub 2018 Jun 21.
- Background: PubMed 27631981Plawecki M, Lheritier E, Clavarino G, Jourde-Chiche N, Ouili S, Paul S, Gout E, Sarrot-Reynauld F, Bardin N, Boelle PY, Chiche L, Bouillet L, Thielens NM, Cesbron JY, Dumestre-Perard C. Association between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients with Systemic Lupus Erythematosus. PLoS One. 2016 Sep 15;11(9):e0160879. doi: 10.1371/journal.pone.0160879. eCollection 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus Nephritis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploration of the inhibition of anti-ficolin-3 antibodies purified from the serum of 14 patients with active lupus nephritis in ficolin-3-dependent necrotic cells recognition. (time frame: Measure at day of inclusion = TO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842787, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.