Epi_LN: Epigenetics in Lupus Nephritis

• Sponsor: University of Göttingen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04648059
• Collaborator: King's College London (Other), Università degli Studi di Brescia (Other)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	Phase
Systemic Lupus Erythematosus; Lupus Nephritis	Diagnostic Test: Blood sampling

Study Design

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

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Methylated CpG-rich DNA fragments [12 months]

   it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Göttingen	Göttingen	Lower Saxony	Germany	37075

Sponsors and Collaborators

• University of Göttingen
• King's College London
• Università degli Studi di Brescia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Korsten, Principal Investigator, University of Göttingen
• ClinicalTrials.gov Identifier: NCT04648059
• Other Study ID Numbers: 28/9/17
• First Posted: Dec 1, 2020
• Last Update Posted: Mar 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Korsten, Principal Investigator, University of Göttingen: Epigenetics; Methylation; Toll-like receptors; Fibrosis
• Additional relevant MeSH terms: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Mar 14, 2022