Urinary T Cell Biomarker for Prediction in Lupus Nephritis

• Conditions: Lupus Nephritis
• Interventions: Diagnostic Test: Flow cytometry analysis of urine samples

• Registration Number: NCT04320797
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-30
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active lupus nephritis	Flow cytometry analysis of urine samples	Patients with proliferative lupus nephritis (Class III and IV)
Control	Flow cytometry analysis of urine samples	Patients with systemic lupus erythematodes without lupus nephritis or lupus nephritis I, II or VI

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Diagnosis of proliferative lupus nephritis in patients with systemic lupus erythematodes (SLE)	6 months	Diagnosis according to initial T cell count
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.

Trial Locations

Locations (2)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

The Royal Free London; 🇬🇧 London, United Kingdom