Lupus Nephritis
Conditions
Keywords
lupus nephritis, systemic lupus erythematodes, urinary biomarker, outcome, prediction, urinary effector memory T lymphocytes, glomerulonephritis, non-invasive biomarker, flow cytometry, treatment outcome, CD4-positive T-lymphocytes/immunology
Brief summary
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.
Interventions
DIAGNOSTIC_TESTFlow 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
Sponsors
Berlin Institute of Health
Charite University, Berlin, Germany
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis | 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distinction between proliferative LN (class III and class IV) and non-proliferative LN (classes I, II and VI) | 6 months | — |
| Analysis of patient 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 lupus nephritis | 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 lupus nephritis. The frequency of effector/memory CD8+ T lymphocytes is higher in patients with non- or partial response. |
| Diagnosis of proliferative lupus nephritis in patients with systemic lupus erythematodes (SLE) | 6 months | Diagnosis according to initial T cell count |
Countries
Germany, United Kingdom
Outcome results
None listed