Epigenetics in Lupus Nephritis

NCT ID: NCT04648059

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Systemic Lupus Erythematosus Lupus Nephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lupus nephritis +ve

This group consists of patients with Lupus nephritis

Blood sampling

Intervention Type DIAGNOSTIC_TEST

Blood sampling will be performed to allow analyses of epigenetic markers

Lupus nephritis -ve

This group consist of patients with SLE without Lupus nephritis

Blood sampling

Intervention Type DIAGNOSTIC_TEST

Blood sampling will be performed to allow analyses of epigenetic markers

Interventions

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Blood sampling

Blood sampling will be performed to allow analyses of epigenetic markers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role lead

Responsible Party

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Peter Korsten

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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PETER KORSTEN, MD

Role: CONTACT

055139 ext. 8904

Facility Contacts

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PETER KORSTEN

Role: primary

0551398904

Other Identifiers

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28/9/17

Identifier Type: -

Identifier Source: org_study_id

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