Urinary T Cell Biomarker for Prediction in Lupus Nephritis

N/AUnknownNCT04320797

Charite University, Berlin, Germany79 enrolled

Overview

Urinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. 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 lupus nephritis (LN) 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 Type

OBSERVATIONAL

Enrollment

Conditions

Lupus Nephritis

Interventions

Flow cytometry analysis of urine samplesDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy proven lupus nephritis * In absence of a biopsy a SLEDAI of at least 10 \& at least two renal elements of the renal SLEDAI (rSLEDAI) * Informed consent * Diagnosis of SLE according to the American College of Rheumatology (ACR) criteria Exclusion Criteria: * Biopsy-proven non-SLE related disease * Urinary tract infection * Active menstrual bleeding * Kidney transplantation during observation time

Locations (2)

Charité - Universitätsmedizin Berlin

Berlin, Germany

The Royal Free London

London, United Kingdom

Outcomes

Primary Outcomes

Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis

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 lupus nephritis. The frequency of effector/memory CD4+ T lymphocytes is higher in patients with non- or partial response. * Complete response at 24 weeks: the return to within 10 percent of normal values of serum creatinine levels, proteinuria, and urine sediment. * Partial response at 24 weeks: improvement of 50 percent in all abnormal renal measurements, without worsening - within 10 percent - of any measurement

Time frame: 6 months

Secondary Outcomes

Distinction between proliferative LN (class III and class IV) and non-proliferative LN (classes I, II and VI)

Time frame: 6 months

Analysis of patient with persistent renal abnormalities as partial response

Time frame: 6 months

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

Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis

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 lupus nephritis. The frequency of effector/memory CD8+ T lymphocytes is higher in patients with non- or partial response.

Time frame: 6 months

Diagnosis of proliferative lupus nephritis in patients with systemic lupus erythematodes (SLE)

Diagnosis according to initial T cell count

Data from ClinicalTrials.gov

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