Urinary T Cell Biomarker for Prediction in Lupus Nephritis

• Conditions: Lupus Nephritis

• 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

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