Systemic Lupus ErythematosusNCT05362812
Prediction of Lupus Renal Flares Study
An observational study of Systemic Lupus Erythematosus, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In patients with systemic lupus erythematosus, urinary CD4+ T cells may have the potential to predict subsequent renal flares in the next 6 months. Patients with systemic lupus erythematosus from our outpatient clinic will be included in this cross-sectional, prospective biomarker study regardless of disease activity… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 28 Feb 2022to 1 Apr 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic lupus erythematosus from the outpatient clinic of the Department of Rheumatology and Clinical Immunology, University Hospital Charité, Berlin
Who may be able to join
- Informed consent
- Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria Stable immunosuppressive or biologic background therapy within the last 6 months prior to inclusion
Who cannot join
- Age < 18
- Inability to consent
- Urinary tract infection (defined by detection of nitrite or positive urine culture)
- Patients on chronic dialysis
- Concomitant other autoimmune disease
Trial locations and contacts
1 site in 1 country.
Johanna S Kotzbauer contact
Germany1 site, 1 recruiting
- Recruiting
Department of Nephrology and Intensive Care, Charite University Hospital
Berlin, 10117
Philipp Enghard, PD Dr. med., 030 450 614016, philipp.enghard@charite.de
About this study
In patients with systemic lupus erythematosus, urinary CD4+ T cells may have the potential to predict subsequent renal flares in the next 6 months. Patients with systemic lupus erythematosus from our outpatient clinic will be included in this cross-sectional, prospective biomarker study regardless of disease activity, clinical phenotype, and disease duration or baseline therapy. Urinary T cells will be analyzed by flow cytometry. 6 months after sample collection a clinical follow-up will be conducted to assess the occurrence of either recurrent or de novo renal flares.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Lupus Nephritis, Flow Cytometry, CD4-Positive T-Lymphocytes, Biomarker, Urine Specimen Collection
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with systemic lupus erythematosus | Diagnostic Test: Flow cytometry analysis of urine samples. Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and B cell panel with fluorochromes. T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD38, CD279; B cell panel: CD19, CD20, CD27, CD38, CD21, IgD, CXCR5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal flares within the next 6 months
To evaluate whether the number of urinary CD4+ T cells has the potential to predict subsequent renal flares in the next 6 months.
Renal flares will be defined as an increase of proteinuria by > 0.5 g/g creatinine or an increase in creatinine by 30% without other likely explanation or a novel kidney biopsy demonstrating lupus nephritis.
Measured: 6 months
Secondary outcomes (5)
To investigate whether the phenotype of urinary T cell subsets can predict renal involvement or subsequent renal flares in preexisting LN (CD4+ and CD8+ T cells subsets).
Measured: 6 months
To investigate whether the number and phenotype of urinary B- and plasma cell subsets can predict renal involvement or subsequent renal flares in preexisting LN
Measured: 6 months
To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement.
Measured: 6 months
To assess whether urinary or peripheral blood T- and B cell subsets or IFN-I activity can predict the incidence of mild/moderate or severe flares of SLE according to the SELENA-SLEDAI Flare Index (SFI)
Measured: 6 months
Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start28 Feb 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Enghard, Charite University, Berlin, Germany
- Investigators
- Philipp Enghard, MD, Principal investigator, Department of Nephrology and Intensive Care, Charite University HospitalTobias Alexander, MD, Principal investigator, Department of Rheumatology and Clinical Immunology, Charite University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362812
- Sponsor's protocol ID
- PreLuFlare
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Enghard P, Rieder C, Kopetschke K, Klocke JR, Undeutsch R, Biesen R, Dragun D, Gollasch M, Schneider U, Aupperle K, Humrich JY, Hiepe F, Backhaus M, Radbruch AH, Burmester GR, Riemekasten G. Urinary CD4 T cells identify SLE patients with proliferative lupus nephritis and can be used to monitor treatment response. Ann Rheum Dis. 2014 Jan;73(1):277-83. doi: 10.1136/annrheumdis-2012-202784. Epub 2013 Mar 8.
PubMed 23475982Rose T, Grutzkau A, Klotsche J, Enghard P, Flechsig A, Keller J, Riemekasten G, Radbruch A, Burmester GR, Dorner T, Hiepe F, Biesen R. Are interferon-related biomarkers advantageous for monitoring disease activity in systemic lupus erythematosus? A longitudinal benchmark study. Rheumatology (Oxford). 2017 Sep 1;56(9):1618-1626. doi: 10.1093/rheumatology/kex220.
PubMed 28859328Burns M, Ostendorf L, Biesen R, Grutzkau A, Hiepe F, Mei HE, Alexander T. Dysregulated CD38 Expression on Peripheral Blood Immune Cell Subsets in SLE. Int J Mol Sci. 2021 Feb 28;22(5):2424. doi: 10.3390/ijms22052424.
PubMed 33670902
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Lupus Renal Flares Study
- ClinicalTrials.gov ID
- NCT05362812
- Acronym / sponsor ID
- PreLuFlare
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Lupus Nephritis, Flow Cytometry, CD4-Positive T-Lymphocytes, Biomarker, Urine Specimen Collection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 5 May 2022 (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.
In patients with systemic lupus erythematosus, urinary CD4+ T cells may have the potential to predict subsequent renal flares in the next 6 months. Patients with systemic lupus erythematosus from our outpatient clinic will be included in this cross-sectional, prospective biomarker study regardless of disease activity, clinical phenotype, and disease duration or baseline therapy. Urinary T cells will be analyzed by flow cytometry. 6 months after sample collection a clinical follow-up will be conducted to assess the occurrence of either recurrent or de novo renal flares.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with systemic lupus erythematosus | – | –Diagnostic Test: Flow cytometry analysis of urine samples. Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and B cell panel with fluorochromes. T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD38, CD279; B cell panel: CD19, CD20, CD27, CD38, CD21, IgD, CXCR5 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic lupus erythematosus from the outpatient clinic of the Department of Rheumatology and Clinical Immunology, University Hospital Charité, Berlin
Key inclusion criteria (2 listed)
- Informed consent
- Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria Stable immunosuppressive or biologic background therapy within the last 6 months prior to inclusion
Key exclusion criteria (5 listed)
- Age < 18
- Inability to consent
- Urinary tract infection (defined by detection of nitrite or positive urine culture)
- Patients on chronic dialysis
- Concomitant other autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal flares within the next 6 months
Time frame: 6 months
To evaluate whether the number of urinary CD4+ T cells has the potential to predict subsequent renal flares in the next 6 months. Renal flares will be defined as an increase of proteinuria by > 0.5 g/g creatinine or an increase in creatinine by 30% without other likely explanation or a novel kidney biopsy demonstrating lupus nephritis.
5 secondary outcomes
To investigate whether the phenotype of urinary T cell subsets can predict renal involvement or subsequent renal flares in preexisting LN (CD4+ and CD8+ T cells subsets).
Time frame: 6 months
To investigate whether the number and phenotype of urinary B- and plasma cell subsets can predict renal involvement or subsequent renal flares in preexisting LN
Time frame: 6 months
To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement.
Time frame: 6 months
To assess whether urinary or peripheral blood T- and B cell subsets or IFN-I activity can predict the incidence of mild/moderate or severe flares of SLE according to the SELENA-SLEDAI Flare Index (SFI)
Time frame: 6 months
Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 23475982Enghard P, Rieder C, Kopetschke K, Klocke JR, Undeutsch R, Biesen R, Dragun D, Gollasch M, Schneider U, Aupperle K, Humrich JY, Hiepe F, Backhaus M, Radbruch AH, Burmester GR, Riemekasten G. Urinary CD4 T cells identify SLE patients with proliferative lupus nephritis and can be used to monitor treatment response. Ann Rheum Dis. 2014 Jan;73(1):277-83. doi: 10.1136/annrheumdis-2012-202784. Epub 2013 Mar 8.
- Background: PubMed 28859328Rose T, Grutzkau A, Klotsche J, Enghard P, Flechsig A, Keller J, Riemekasten G, Radbruch A, Burmester GR, Dorner T, Hiepe F, Biesen R. Are interferon-related biomarkers advantageous for monitoring disease activity in systemic lupus erythematosus? A longitudinal benchmark study. Rheumatology (Oxford). 2017 Sep 1;56(9):1618-1626. doi: 10.1093/rheumatology/kex220.
- Background: PubMed 33670902Burns M, Ostendorf L, Biesen R, Grutzkau A, Hiepe F, Mei HE, Alexander T. Dysregulated CD38 Expression on Peripheral Blood Immune Cell Subsets in SLE. Int J Mol Sci. 2021 Feb 28;22(5):2424. doi: 10.3390/ijms22052424.
- Individual participant dataSharing planned: Undecided
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Johanna S Kotzbauer contact
Philipp Enghard, MD principal investigator
Department of Nephrology and Intensive Care, Charite University Hospital
Tobias Alexander, MD principal investigator
Department of Rheumatology and Clinical Immunology, Charite University Hospital
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, run by Charite University, Berlin, Germany 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 5 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 10 May 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 Philipp Enghard, PD Dr. med. (030 450 614016, philipp.enghard@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal flares within the next 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362812, which also lists 3 linked publications.
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 10 May 2022.