Urinary T Cell Biomarker for Prediction in ANCA Glomerulonephritis

• Conditions: Glomerulonephritis Acute
• Interventions: Diagnostic Test: Flow cytometry analysis of urine samples

• Registration Number: NCT04320667
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-19
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-25
• Primary Completion: 2021-09-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active ANCA glomerulonephritis	Flow cytometry analysis of urine samples	Patients with ANCA related disease (Microscopic Polyangiitis, Granulomatosis with Polyangiitis or Churg-Strauss Syndrome) and active renal involvement
Control	Flow cytometry analysis of urine samples	Patients with ANCA related disease (MPA, GPA, CSS) without renal involvement or complete remission

Primary Outcome Measures

Name	Time	Method
Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with active ANCA-assosciated glomerulonephritis	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.

Secondary Outcome Measures

Name	Time	Method
Diagnosis of active glomerulonephritis in Patients with ANCA associated vasculitis	6 months	Diagnosis according to initial T cell count
Analysis of patients with persistent renal abnormalities as partial response	6 months
Prediction of complete or partial response according to normalization of the amount of urinary T cells at time point 2 and 4	6 months
Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with active ANCA-assosciated glomerulonephritis	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.
Subgroup analysis according to treatment	6 months

Trial Locations

Locations (2)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Deutschland, Germany

The Royal Free London; 🇬🇧 London, United Kingdom