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NCT04648059 Clinical Trial

Epigenetics in Lupus Nephritis

Systemic Lupus Erythematosus Clinical Trial

— Epi_LN  

Official title:
Unmethylated CpG-rich DNA Fragments in TLR-mediated Renal Fibrogenesis of Lupus Nephritis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04648059
Other study ID # 28/9/17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date June 30, 2023

Study information
Verified date February 2022
Source University of Göttingen
Contact PETER KORSTEN, MD
Phone 055139
Email peter.korsten@med.uni-goettingen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sampling
Blood sampling will be performed to allow analyses of epigenetic markers

Locations
Country Name City State
Germany University Medical Center Göttingen Göttingen Lower Saxony

Sponsors (3)
Lead Sponsor Collaborator
University of Göttingen King's College London, Università degli Studi di Brescia

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Methylated CpG-rich DNA fragments it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood 12 months
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