Systemic Lupus ErythematosusEpi_LNNCT04648059
Epigenetics in Lupus Nephritis
An observational study of Systemic Lupus Erythematosus and Lupus Nephritis, run by University of Göttingen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis
- What is being tested?
- Blood sampling
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- patients not able or unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
PETER KORSTEN, 0551398904, peter.korsten@med.uni-goettingen.de
About this study
Official title: 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.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Being tested
- Blood sampling
- Keywords
- Epigenetics, Methylation, Toll-like receptors, Fibrosis
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Blood sampling will be performed to allow analyses of epigenetic markers
| Study group | Role | What they receive |
|---|---|---|
| Lupus nephritis +ve | This group consists of patients with Lupus nephritis Receives: Diagnostic Test: Blood sampling | |
| Lupus nephritis -ve | This group consist of patients with SLE without Lupus nephritis Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylated CpG-rich DNA fragments
it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Università degli Studi di Brescia
- Responsible party
- Principal investigator, Peter Korsten, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648059
- Sponsor's protocol ID
- 28/9/17
- Acronym
- Epi_LN
- Status last verified
- Feb 2022
- First submitted
- 23 Nov 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unmethylated CpG-rich DNA Fragments in TLR-mediated Renal Fibrogenesis of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT04648059
- Acronym / sponsor ID
- Epi_LN / 28/9/17
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Keywords
- Epigenetics, Methylation, Toll-like receptors, Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- King's College London, Università degli Studi di Brescia
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupus nephritis +ve | – | Diagnostic Test: Blood samplingThis group consists of patients with Lupus nephritis |
| Lupus nephritis -ve | – | Diagnostic Test: Blood samplingThis group consist of patients with SLE without Lupus nephritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- patients not able or unwilling to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling will be performed to allow analyses of epigenetic markers | Diagnostic test | Lupus nephritis +ve, Lupus nephritis -ve |
Primary outcome
Methylated CpG-rich DNA fragments
Time frame: 12 months
it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Lupus Nephritis, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PETER KORSTEN, MD (055139 ext. 8904, peter.korsten@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methylated CpG-rich DNA fragments (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.