Urinary T Cell Biomarker for Prediction in ANCA Glomerulonephritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04320667
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Charite University, Berlin, Germany
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Philipp Enghard, PD Dr. med.
Principal Investigator Affiliation Charite University, Berlin, Germany
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries Germany, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glomerulonephritis Acute
Arms & Interventions

Arms

: Active ANCA glomerulonephritis

Patients with ANCA related disease (Microscopic Polyangiitis, Granulomatosis with Polyangiitis or Churg-Strauss Syndrome) and active renal involvement

: Control

Patients with ANCA related disease (MPA, GPA, CSS) without renal involvement or complete remission

Interventions

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 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Charité - Universitätsmedizin Berlin, Berlin, Deutschland, Germany

Status

Recruiting

Address

Charité - Universitätsmedizin Berlin

Berlin, Deutschland, 10117

Site Contact

Luka Prskalo

luka.prskalo@charite.de

+4917630130373

The Royal Free London, London, United Kingdom

Status

Recruiting

Address

The Royal Free London

London, , NW3 2QG

Site Contact

Alan Salama, PhD

alan.salama@nhs.net

+4917630130373

Terms of Service

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