Glomerulonephritis AcuteNCT04320667
Urinary T Cell Biomarker for Prediction in ANCA Glomerulonephritis
An observational study of Glomerulonephritis Acute, 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 ANCA associated glomerulonephritis (ANCA GN). 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 ANCA GN after 6 months of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerulonephritis Acute
- What is being tested?
- Flow cytometry analysis of urine samples
- How many people
- 79 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Nov 2019to Dec 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, The Royal Free Hospital
Who may be able to join
- Informed consent
- Biopsy proven ANCA related glomerulonephritis
- In absence of biopsy clinical diagnosis of ANCA related glomerulonephritis
Who cannot join
- Biopsy proven non-ANCA related kidney disease
- Active menstrual bleeding
- Urinary tract infection
- Kidney transplantation during observational period
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 ANCA Glomerulonephritis
Urinary T lymphocytes may be predictive for clinical outcome in patients with ANCA associated glomerulonephritis (ANCA GN). 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 ANCA GN 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
- Glomerulonephritis Acute
- Being tested
- Flow cytometry analysis of urine samples
- Keywords
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Pauci-Immune Vasculitis, Churg-Strauss Syndrome, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, 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
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Churg-Strauss Syndrome, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, 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 ANCA glomerulonephritis | Patients with ANCA related disease (Microscopic Polyangiitis, Granulomatosis with Polyangiitis or Churg-Strauss Syndrome) and active renal involvement Receives: Diagnostic Test: Flow cytometry analysis of urine samples | |
| Control | Patients with ANCA related disease (MPA, GPA, CSS) without renal involvement or complete remission 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 active ANCA-assosciated glomerulonephritis
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 active ANCA-assosciated glomerulonephritis. The frequency of effector/memory CD4+ T lymphocytes is higher in patients with non- or partial response.
Complete response at 24 weeks: BVAS = 0 Partial response at 24 weeks: at least one renal element of the BVAS score.
Measured: 6 months
Secondary outcomes (5)
Analysis of patients with persistent renal abnormalities as partial response
Measured: 6 months
Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with active ANCA-assosciated glomerulonephritis
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 active ANCA-assosciated glomerulonephritis. The frequency of effector/memory CD8+ T lymphocytes is higher in patients with non- or partial response.
Measured: 6 months
Subgroup analysis according to treatment
Measured: 6 months
Diagnosis of active glomerulonephritis in Patients with ANCA associated vasculitis
Diagnosis according to initial T cell count
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
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 start19 Nov 2019
- Primary completion1 Sep 2021
- Study completionDec 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 Glomerulonephritis AcuteStudies 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
- NCT04320667
- Sponsor's protocol ID
- ANCAFLURINOCYTE
- Status last verified
- Jul 2022
- First submitted
- 23 Mar 2020
- Last updated
- 29 Jul 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 23475982Abdulahad WH, Kallenberg CG, Limburg PC, Stegeman CA. Urinary CD4+ effector memory T cells reflect renal disease activity in antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2009 Sep;60(9):2830-8. doi: 10.1002/art.24747.
PubMed 19714581Lieberthal JG, Cuthbertson D, Carette S, Hoffman GS, Khalidi NA, Koening CL, Langford CA, Maksimowicz-McKinnon K, Seo P, Specks U, Ytterberg SR, Merkel PA, Monach PA; Vasculitis Clinical Research Consortium. urinary biomarkers in relapsing antineutrophil cytoplasmic antibody-associated vasculitis. J Rheumatol. 2013 May;40(5):674-83. doi: 10.3899/jrheum.120879. Epub 2013 Apr 1.
PubMed 23547217Tomasson G, Grayson PC, Mahr AD, Lavalley M, Merkel PA. Value of ANCA measurements during remission to predict a relapse of ANCA-associated vasculitis--a meta-analysis. Rheumatology (Oxford). 2012 Jan;51(1):100-9. doi: 10.1093/rheumatology/ker280. Epub 2011 Oct 29.
PubMed 22039267
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 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 ANCA Glomerulonephritis
- ClinicalTrials.gov ID
- NCT04320667
- Acronym / sponsor ID
- ANCAFLURINOCYTE
- Conditions
- Glomerulonephritis Acute
- Keywords
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Pauci-Immune Vasculitis, Churg-Strauss Syndrome, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, urinary biomarker, outcome, prediction,
- 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
- 19 Nov 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- Dec 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 ANCA associated glomerulonephritis (ANCA GN). 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 ANCA GN 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 ANCA glomerulonephritis | – | Diagnostic Test: Flow cytometry analysis of urine samplesPatients with ANCA related disease (Microscopic Polyangiitis, Granulomatosis with Polyangiitis or Churg-Strauss Syndrome) and active renal involvement |
| Control | – | Diagnostic Test: Flow cytometry analysis of urine samplesPatients with ANCA related disease (MPA, GPA, CSS) without renal involvement or complete remission |
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, The Royal Free Hospital
Key inclusion criteria (3 listed)
- Informed consent
- Biopsy proven ANCA related glomerulonephritis
- In absence of biopsy clinical diagnosis of ANCA related glomerulonephritis
Key exclusion criteria (4 listed)
- Biopsy proven non-ANCA related kidney disease
- Active menstrual bleeding
- Urinary tract infection
- Kidney transplantation during observational period
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 ANCA glomerulonephritis, Control |
Primary outcome
Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with active ANCA-assosciated glomerulonephritis
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 active ANCA-assosciated glomerulonephritis. The frequency of effector/memory CD4+ T lymphocytes is higher in patients with non- or partial response. Complete response at 24 weeks: BVAS = 0 Partial response at 24 weeks: at least one renal element of the BVAS score.
5 secondary outcomes
Analysis of patients with persistent renal abnormalities as partial response
Time frame: 6 months
Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with active ANCA-assosciated glomerulonephritis
Time frame: 6 months
Subgroup analysis according to treatment
Time frame: 6 months
Diagnosis of active glomerulonephritis in Patients with ANCA associated vasculitis
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 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 19714581Abdulahad WH, Kallenberg CG, Limburg PC, Stegeman CA. Urinary CD4+ effector memory T cells reflect renal disease activity in antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2009 Sep;60(9):2830-8. doi: 10.1002/art.24747.
- Background: PubMed 23547217Lieberthal JG, Cuthbertson D, Carette S, Hoffman GS, Khalidi NA, Koening CL, Langford CA, Maksimowicz-McKinnon K, Seo P, Specks U, Ytterberg SR, Merkel PA, Monach PA; Vasculitis Clinical Research Consortium. urinary biomarkers in relapsing antineutrophil cytoplasmic antibody-associated vasculitis. J Rheumatol. 2013 May;40(5):674-83. doi: 10.3899/jrheum.120879. Epub 2013 Apr 1.
- Background: PubMed 22039267Tomasson G, Grayson PC, Mahr AD, Lavalley M, Merkel PA. Value of ANCA measurements during remission to predict a relapse of ANCA-associated vasculitis--a meta-analysis. Rheumatology (Oxford). 2012 Jan;51(1):100-9. doi: 10.1093/rheumatology/ker280. Epub 2011 Oct 29.
- Individual participant dataSharing planned: Undecided
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 Glomerulonephritis Acute, 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 3 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 29 Jul 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 active ANCA-assosciated glomerulonephritis (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 NCT04320667, 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 29 Jul 2022.