Clinical trial NCT04320667: Urinary T Cell Biomarker for Prediction in ANCA Glomerulonephritis
Official title: Phenotype of Urinary CD4+ T Cells as Biomarkers for Prediction of Outcome in ANCA Glomerulonephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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,
urinary effector memory T lymphocytes
glomerulonephritis
non-invasive biomarker
flow cytometry
treatment outcome
CD4-Positive T-Lymphocytes/immunology
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Berlin Institute of Health
First posted: 2020-03-25
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at medical wards of Charité Universitätsmedizin Berlin and University College London, The Royal Free Hospital

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Biopsy proven ANCA related glomerulonephritis
* In absence of biopsy clinical diagnosis of ANCA related glomerulonephritis

Exclusion Criteria:

* Biopsy proven non-ANCA related kidney disease
* Active menstrual bleeding
* Urinary tract infection
* Kidney transplantation during observational period

Primary outcomes:
measure: Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with active ANCA-assosciated glomerulonephritis
timeFrame: 6 months
Secondary outcomes:
measure: Analysis of patients with persistent renal abnormalities as partial response
timeFrame: 6 months
measure: Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with active ANCA-assosciated glomerulonephritis
timeFrame: 6 months
measure: Subgroup analysis according to treatment
timeFrame: 6 months
measure: Diagnosis of active glomerulonephritis in Patients with ANCA associated vasculitis
timeFrame: 6 months
measure: Prediction of complete or partial response according to normalization of the amount of urinary T cells at time point 2 and 4
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
state: Deutschland
city: London
country: United Kingdom
facility: The Royal Free London
Study officials:
affiliation: Charite University, Berlin, Germany
name: Philipp Enghard, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Abdulahad 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.
citation: Lieberthal 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.
citation: Tomasson 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.