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Epigenetics in Lupus Nephritis (Epi_LN)

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ClinicalTrials.gov Identifier: NCT04648059
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : December 1, 2020
Sponsor:
Collaborators:
King's College London
Università degli Studi di Brescia
Information provided by (Responsible Party):
Peter Korsten, University of Göttingen

Brief Summary:
This is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from Systemic Lupus erythematosus. The aim of the study is to analyze whether circulating DNA fragments are 1) different in patients with or without Lupus nephritis and 2) present and detectable in the circulation before the development of Lupus nephritis.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Lupus Nephritis Diagnostic Test: Blood sampling

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unmethylated CpG-rich DNA Fragments in TLR-mediated Renal Fibrogenesis of Lupus Nephritis
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023


Group/Cohort Intervention/treatment
Lupus nephritis +ve
This group consists of patients with Lupus nephritis
Diagnostic Test: Blood sampling
Blood sampling will be performed to allow analyses of epigenetic markers

Lupus nephritis -ve
This group consist of patients with SLE without Lupus nephritis
Diagnostic Test: Blood sampling
Blood sampling will be performed to allow analyses of epigenetic markers




Primary Outcome Measures :
  1. Methylated CpG-rich DNA fragments [ Time Frame: 12 months ]
    it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood


Biospecimen Retention:   Samples With DNA
Circulating CpG-rich DNA fragments


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of a sample of patients with systemic lupus nephritis (SLE). There will be analyses for the presence of epigenetic markers (methylated CpG-rich DNA fragments) between two groups: 1) patients with SLE with Lupus nephritis (LN) and 2) patients with SLE without LN. In the first phase of the study, a cross-sectional sample of patients will be analyzed. In the second phase of the study, patient samples will be prospectively analyzed for the presence of these markers.
Criteria

Inclusion Criteria:

  • Diagnosis of systemic lupus erythematosus according to the current classification criteria
  • a subgroup requires the presence of Lupus nephritis (no restriction to specific LN histologic subtypes)

Exclusion Criteria:

  • patients not able or unwilling to provide written informed consent

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): NCT04648059


Contacts
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Contact: PETER KORSTEN, MD 055139 ext 8904 peter.korsten@med.uni-goettingen.de

Locations
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Germany
University Medical Center Göttingen Recruiting
Göttingen, Lower Saxony, Germany, 37075
Contact: PETER KORSTEN    0551398904    peter.korsten@med.uni-goettingen.de   
Sponsors and Collaborators
University of Göttingen
King's College London
Università degli Studi di Brescia
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Responsible Party: Peter Korsten, Dr. Peter Korsten, University of Göttingen
ClinicalTrials.gov Identifier: NCT04648059    
Other Study ID Numbers: 28/9/17
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Peter Korsten, University of Göttingen:
Epigenetics
Methylation
Toll-like receptors
Fibrosis
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis