Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive ANCA-associated Glomerulonephritis (PRE-FLARED)

November 11, 2023 updated by: Philipp Enghard, Charite University, Berlin, Germany

Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive Anti-neutrophil Cytoplasmic Antibody (ANCA) Associated Glomerulonephritis

Urinary CD4+ and CD8+ T lymphocytes may predict renal flares in patients with inactive ANCA-associated vasculitis and thus serve as early non-invasive biomarkers. Urine samples of patients with inactive renal ANCA-vasculitis will be analysed by flow cytometry and compared to clinical outcome after 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data of previous studies have shown that counts of urinary T lymphocyte subsets correlate with disease activity in several immunological renal diseases, e.g. ANCA-associated glomerulonephritis. Thus, study authors hypothesise that CD4+, respectively CD8+, T effector memory lymphocytes found in urine samples of patients with inactive ANCA-vasculitis predict subsequent renal flares. Therefore, quantification of these cellular subsets might reliably predict relapse of ANCA associated glomerulonephritis at an early stage. In a prospective experimental study urine of patients with ANCA-vasculitis and no renal involvement or patients in renal remission will be analysed by flow cytometry. After 6 months of observation, clinical outcome and potential renal relapse will be determined and correlated to initial T lymphocyte count.

Study Type

Observational

Enrollment (Actual)

100

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
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany, 10117
        • Charite - Universitatsmedizin Berlin

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

Sampling Method

Probability Sample

Study Population

Patients in medical wards or at outpatient departments of 2 facilities:

  • Charité - Universitätsmedizin Berlin
  • Helios Klinikum Berlin-Buch

Description

Inclusion Criteria:

  • diagnosed ANCA-associated vasculitis (clinical diagnosis of granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions AND positive test for proteinase 3-ANCA or myeloperoxidase-ANCA)
  • no currently active renal involvement (defined as BVAS = 0 with exception of hematuria or proteinuria as signs of renal scars)
  • written and informed consent

Exclusion Criteria:

  • urinary tract infection
  • active menstrual bleeding
  • active renal involvement
  • other active renal disease (e.g. diabetic nephropathy)

Initially, we defined treatment with rituximab as exclusion criteria. However, upon closer examination, we recognized that this exclusion criterion was overly restrictive and may have inadvertently excluded eligible participants who met our other inclusion criteria. As a result of this reassessment, we have revised our exclusion criteria to no longer exclude individuals solely on the basis of receiving rituximab treatment.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No renal involvement
Patients with ANCA-vasculitis and no ANCA-associated renal involvement in disease history
Diagnostic test: Analysis of urine samples with flow cytometry

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
Renal remission
Patient with ANCA-vasculitis in renal remission
Diagnostic test: Analysis of urine samples with flow cytometry

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
Prediction of renal relapse after six months depending initial CD4+ count
Time Frame: 6 months
  • relapse defined as Birmingham Vasculitis Activity Score (BVAS) > 1 + at least one renal element or
  • intensified treatment regime (Prednisolon equivalent > 20 mg/d or novel induction treatment with Rituximab or Cyclophosphamide)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of renal relapse after six months depending initial CD8+ count
Time Frame: 6 months
6 months
Prediction of renal relapse after six months depending initial CD4+/CD8+ subsets
Time Frame: 6 months
Subsets: T effector memory cells (CD45RO+/CCR7-)
6 months
Prediction of renal relapse after 12 months depending initial CD4+ count
Time Frame: 12 months
12 months
Prediction of renal relapse after 12 months depending initial CD8+ count
Time Frame: 12 months
12 months
Prediction of renal relapse after 12 months depending initial CD4+/CD8+ subsets
Time Frame: 12 months
Subsets: T effector memory cells (CD45RO+/CCR7-)
12 months

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Philipp Enghard, Charite University, Berlin, Germany
  • Principal Investigator: Adrian Schreiber, PD Dr. med., Charite University, Berlin, Germany

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)

May 1, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRE-FLARED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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