Lupus NephritisNCT04320797
Urinary T Cell Biomarker for Prediction in Lupus Nephritis
An observational study of Lupus Nephritis, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
Trial summary
Urinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Flow cytometry analysis of urine samples
- Type of treatment
- Injection or infusion
- How many people
- 79 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jul 2019to Sep 2022
- 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: Patients at medical wards of Charité Universitätsmedizin Berlin and University College London
Who may be able to join
- Biopsy proven lupus nephritis
- In absence of a biopsy a SLEDAI of at least 10 \& at least two renal elements of the renal SLEDAI (rSLEDAI)
- Informed consent
- Diagnosis of SLE according to the American College of Rheumatology (ACR) criteria
Who cannot join
- Biopsy-proven non-SLE related disease
- Urinary tract infection
- Active menstrual bleeding
- Kidney transplantation during observation time
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phenotype of Urinary CD4+ T Cells as Biomarkers for Prediction of Outcome in Lupus Nephritis
Urinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. In a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). Treatment will be performed to the discretion of the treating clinician. After 6 months of treatment response will be determined as either complete response or partial response.
- Conditions
- Lupus Nephritis
- Being tested
- Flow cytometry analysis of urine samples
- Keywords
- lupus nephritis, systemic lupus erythematodes, urinary biomarker, outcome, prediction, urinary effector memory T lymphocytes, glomerulonephritis, non-invasive biomarker, flow cytometry, treatment outcome, CD4-positive T-lymphocytes/immunology
- Medical subject headings
- Lupus Nephritis, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometry analysis of urine samplesDiagnostic test
Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and TEC (tubular epithelial cells) panel with fluorochromes.
T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD28, CD279; TEC panel: vimentin, cytokeratine, CD10, CD13, CD227, CD326
| Study group | Role | What they receive |
|---|---|---|
| Active lupus nephritis | Patients with proliferative lupus nephritis (Class III and IV) Receives: Diagnostic Test: Flow cytometry analysis of urine samples | |
| Control | Patients with systemic lupus erythematodes without lupus nephritis or lupus nephritis I, II or VI Receives: Diagnostic Test: Flow cytometry analysis of urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis
Urinary CD4+ effector/memory T cell counts at time point 0 (time of diagnosis) predict clinical outcome (complete or partial response) after 6 months of treatment in patients with lupus nephritis. The frequency of effector/memory CD4+ T lymphocytes is higher in patients with non- or partial response.
- Complete response at 24 weeks: the return to within 10 percent of normal values of serum creatinine levels, proteinuria, and urine sediment.
- Partial response at 24 weeks: improvement of 50 percent in all abnormal renal measurements, without worsening - within 10 percent - of any measurement
Measured: 6 months
Secondary outcomes (5)
Distinction between proliferative LN (class III and class IV) and non-proliferative LN (classes I, II and VI)
Measured: 6 months
Analysis of patient with persistent renal abnormalities as partial response
Measured: 6 months
Prediction of complete or partial response according to normalization of the amount of urinary T cells at time point 2 and 4
Measured: 6 months
Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis
Urinary CD8+ effector/memory T cell counts at time point 0 (time of diagnosis) predict clinical outcome (complete or partial response) after 6 months of treatment in patients with lupus nephritis. The frequency of effector/memory CD8+ T lymphocytes is higher in patients with non- or partial response.
Measured: 6 months
Diagnosis of proliferative lupus nephritis in patients with systemic lupus erythematodes (SLE)
Diagnosis according to initial T cell count
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 posted25 Mar 2020
- Study start30 Jul 2019
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Berlin Institute of Health
- Responsible party
- Principal investigator, Philipp Enghard, Charite University, Berlin, Germany
- Investigators
- Philipp Enghard, PD Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320797
- Sponsor's protocol ID
- SLEFLURINOCYTE
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 23475982Arazi A, Rao DA, Berthier CC, Davidson A, Liu Y, Hoover PJ, Chicoine A, Eisenhaure TM, Jonsson AH, Li S, Lieb DJ, Zhang F, Slowikowski K, Browne EP, Noma A, Sutherby D, Steelman S, Smilek DE, Tosta P, Apruzzese W, Massarotti E, Dall'Era M, Park M, Kamen DL, Furie RA, Payan-Schober F, Pendergraft WF 3rd, McInnis EA, Buyon JP, Petri MA, Putterman C, Kalunian KC, Woodle ES, Lederer JA, Hildeman DA, Nusbaum C, Raychaudhuri S, Kretzler M, Anolik JH, Brenner MB, Wofsy D, Hacohen N, Diamond B; Accelerating Medicines Partnership in SLE network. The immune cell landscape in kidneys of patients with lupus nephritis. Nat Immunol. 2019 Jul;20(7):902-914. doi: 10.1038/s41590-019-0398-x. Epub 2019 Jun 17.
PubMed 31209404Dolff S, Abdulahad WH, Arends S, van Dijk MC, Limburg PC, Kallenberg CG, Bijl M. Urinary CD8+ T-cell counts discriminate between active and inactive lupus nephritis. Arthritis Res Ther. 2013 Feb 27;15(1):R36. doi: 10.1186/ar4189.
PubMed 23445537Kopetschke K, Klocke J, Griessbach AS, Humrich JY, Biesen R, Dragun D, Burmester GR, Enghard P, Riemekasten G. The cellular signature of urinary immune cells in Lupus nephritis: new insights into potential biomarkers. Arthritis Res Ther. 2015 Apr 3;17(1):94. doi: 10.1186/s13075-015-0600-y.
PubMed 25890061
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype of Urinary CD4+ T Cells as Biomarkers for Prediction of Outcome in Lupus Nephritis
- ClinicalTrials.gov ID
- NCT04320797
- Acronym / sponsor ID
- SLEFLURINOCYTE
- Conditions
- Lupus Nephritis
- Keywords
- lupus nephritis, systemic lupus erythematodes, urinary biomarker, outcome, prediction, urinary effector memory T lymphocytes, glomerulonephritis, non-invasive biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Berlin Institute of Health
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 25 Mar 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.
Urinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. In a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). Treatment will be performed to the discretion of the treating clinician. After 6 months of treatment response will be determined as either complete response or partial response.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active lupus nephritis | – | Diagnostic Test: Flow cytometry analysis of urine samplesPatients with proliferative lupus nephritis (Class III and IV) |
| Control | – | Diagnostic Test: Flow cytometry analysis of urine samplesPatients with systemic lupus erythematodes without lupus nephritis or lupus nephritis I, II or VI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at medical wards of Charité Universitätsmedizin Berlin and University College London
Key inclusion criteria (4 listed)
- Biopsy proven lupus nephritis
- In absence of a biopsy a SLEDAI of at least 10 \& at least two renal elements of the renal SLEDAI (rSLEDAI)
- Informed consent
- Diagnosis of SLE according to the American College of Rheumatology (ACR) criteria
Key exclusion criteria (4 listed)
- Biopsy-proven non-SLE related disease
- Urinary tract infection
- Active menstrual bleeding
- Kidney transplantation during observation time
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 |
|---|---|---|
| Flow cytometry analysis of urine samplesUrine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and TEC (tubular epithelial cells) panel with fluorochromes. T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD28, CD279; TEC panel: vimentin, cytokeratine, CD10, CD13, CD227, CD326 | Diagnostic test | Active lupus nephritis, Control |
Primary outcome
Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis
Time frame: 6 months
Urinary CD4+ effector/memory T cell counts at time point 0 (time of diagnosis) predict clinical outcome (complete or partial response) after 6 months of treatment in patients with lupus nephritis. The frequency of effector/memory CD4+ T lymphocytes is higher in patients with non- or partial response. * Complete response at 24 weeks: the return to within 10 percent of normal values of serum creatinine levels, proteinuria, and urine sediment. * Partial response at 24 weeks: improvement of 50 percent in all abnormal renal measurements, without worsening - within 10 percent - of any measurement
5 secondary outcomes
Distinction between proliferative LN (class III and class IV) and non-proliferative LN (classes I, II and VI)
Time frame: 6 months
Analysis of patient with persistent renal abnormalities as partial response
Time frame: 6 months
Prediction of complete or partial response according to normalization of the amount of urinary T cells at time point 2 and 4
Time frame: 6 months
Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis
Time frame: 6 months
Diagnosis of proliferative lupus nephritis in patients with systemic lupus erythematodes (SLE)
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 9 Mar 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 31209404Arazi A, Rao DA, Berthier CC, Davidson A, Liu Y, Hoover PJ, Chicoine A, Eisenhaure TM, Jonsson AH, Li S, Lieb DJ, Zhang F, Slowikowski K, Browne EP, Noma A, Sutherby D, Steelman S, Smilek DE, Tosta P, Apruzzese W, Massarotti E, Dall'Era M, Park M, Kamen DL, Furie RA, Payan-Schober F, Pendergraft WF 3rd, McInnis EA, Buyon JP, Petri MA, Putterman C, Kalunian KC, Woodle ES, Lederer JA, Hildeman DA, Nusbaum C, Raychaudhuri S, Kretzler M, Anolik JH, Brenner MB, Wofsy D, Hacohen N, Diamond B; Accelerating Medicines Partnership in SLE network. The immune cell landscape in kidneys of patients with lupus nephritis. Nat Immunol. 2019 Jul;20(7):902-914. doi: 10.1038/s41590-019-0398-x. Epub 2019 Jun 17.
- Background: PubMed 23445537Dolff S, Abdulahad WH, Arends S, van Dijk MC, Limburg PC, Kallenberg CG, Bijl M. Urinary CD8+ T-cell counts discriminate between active and inactive lupus nephritis. Arthritis Res Ther. 2013 Feb 27;15(1):R36. doi: 10.1186/ar4189.
- Background: PubMed 25890061Kopetschke K, Klocke J, Griessbach AS, Humrich JY, Biesen R, Dragun D, Burmester GR, Enghard P, Riemekasten G. The cellular signature of urinary immune cells in Lupus nephritis: new insights into potential biomarkers. Arthritis Res Ther. 2015 Apr 3;17(1):94. doi: 10.1186/s13075-015-0600-y.
- Individual participant dataSharing planned: Undecided
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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.
Philipp Enghard, PD Dr. med. principal investigator
Charite University, Berlin, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
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 4 inclusion and 4 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 9 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 2 sites in Germany, United Kingdom. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis (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 NCT04320797, which also lists 4 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 9 Mar 2022.