Urinary T Cell Biomarker for Prediction in ANCA Glomerulonephritis

Charité University Medicine Berlin

Status: Active, not recruiting

Conditions: Glomerulonephritis Acute

Treatments: Diagnostic Test: Flow cytometry analysis of urine samples

Study type: Observational

Funder types: Other

Identifiers

NCT04320667

ANCAFLURINOCYTE

Details and patient eligibility

About

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.

Enrollment: 79 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

79 participants in 2 patient groups

Active ANCA glomerulonephritis

Description:

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

Treatment:

Diagnostic Test: Flow cytometry analysis of urine samples

Control

Description:

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

Treatment:

Diagnostic Test: Flow cytometry analysis of urine samples