Epigenetics in Lupus Nephritis (Epi_LN)

February 24, 2022 updated by: Peter Korsten, University of Göttingen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methylated CpG-rich DNA fragments
Time Frame: 12 months
it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Collaborators

King's College London
Università degli Studi di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28/9/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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