Epigenetics in Lupus Nephritis

• Conditions: Systemic Lupus Erythematosus; Lupus Nephritis
• Interventions: Diagnostic Test: Blood sampling

• Registration Number: NCT04648059
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-23
• Study Start: 2020-12-01
• Study First Posted: 2020-12-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-14
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lupus nephritis +ve	Blood sampling	This group consists of patients with Lupus nephritis
Lupus nephritis -ve	Blood sampling	This group consist of patients with SLE without Lupus nephritis

Primary Outcome Measures

Name	Time	Method
Methylated CpG-rich DNA fragments	12 months	it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood

Trial Locations

Locations (1)

University Medical Center Göttingen; 🇩🇪 Göttingen, Lower Saxony, Germany