Urinary T Cell Biomarker for Prediction in ANCA Glomerulonephritis

July 28, 2022 updated by: Philipp Enghard, Charite University, Berlin, Germany

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Deutschland
      • Berlin, Deutschland, Germany, 10117
        • Charité - Universitätsmedizin Berlin
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • The Royal Free London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients at medical wards of Charité Universitätsmedizin Berlin and University College London, The Royal Free Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active ANCA glomerulonephritis
Patients with ANCA related disease (Microscopic Polyangiitis, Granulomatosis with Polyangiitis or Churg-Strauss Syndrome) and active renal involvement
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
Control
Patients with ANCA related disease (MPA, GPA, CSS) without renal involvement or complete remission
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Analysis of patients with persistent renal abnormalities as partial response
Time Frame: 6 months
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
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.
6 months
Subgroup analysis according to treatment
Time Frame: 6 months
6 months
Diagnosis of active glomerulonephritis in Patients with ANCA associated vasculitis
Time Frame: 6 months
Diagnosis according to initial T cell count
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Berlin Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2019

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (ACTUAL)

March 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANCAFLURINOCYTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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