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Urinary T Cell Biomarker for Prediction in Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT04320797
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Berlin Institute of Health
Information provided by (Responsible Party):
Philipp Enghard, 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+ 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.

Condition or disease Intervention/treatment
Lupus Nephritis Diagnostic Test: Flow cytometry analysis of urine samples

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Study Type : Observational
Estimated Enrollment : 79 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Urinary CD4+ T Cells as Biomarkers for Prediction of Outcome in Lupus Nephritis
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Active lupus nephritis
Patients with proliferative lupus nephritis (Class III and IV)
Diagnostic Test: Flow 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


Control
Patients with systemic lupus erythematodes without lupus nephritis or lupus nephritis I, II or VI
Diagnostic Test: Flow 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





Primary Outcome Measures :
  1. Prediction of complete or partial response according to normalization of the amount of urinary T cells. [ Time Frame: 6 months ]

    Urinary CD4+ T cell counts at time point 0 for prediction of clinical outcome in patients with lupus nephritis.

    • 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 :
  1. Distinction between proliferative LN (class III and class IV) and non-proliferative LN (classes I, II and VI) [ Time Frame: 6 months ]
  2. Analysis of patient with persistent renal abnormalities as partial response [ Time Frame: 6 months ]
  3. Phenotype of T cell predictive of complete response (frequency of effector/memory T cells) [ Time Frame: 6 months ]
  4. The frequency of urinary CD8+ effector memory T cells i as biomarker for prediction of outcome in patients with lupus nephritis after six months of therapy [ Time Frame: 6 months ]
  5. Diagnosis of active lupus nephritis in Patients with systemic lupus erythematodes (SLE) [ Time Frame: 6 months ]
    Diagnosis according to initial T cell count


Biospecimen Retention:   Samples With DNA
urine, lymphocytes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at medical wards of Charité Universitätsmedizin Berlin and University College London
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320797


Contacts
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Contact: Luka Prskalo +49 17630130373 luka.prskalo@charite.de
Contact: Philipp Enghard, PD Dr. med. philipp.enghard@charite.de

Locations
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Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Luka Prskalo    +49 17630130373    luka.prskalo@charite.de   
Contact: Philipp Enghard, PD Dr. med.       philipp.enghard@charite.de   
Sub-Investigator: Luka Prskalo         
Principal Investigator: Philipp Enghard, PD Dr. med.         
United Kingdom
The Royal Free London Recruiting
London, United Kingdom, NW3 2QG
Contact: Alan Salama, PhD       alan.salama@nhs.net   
Sponsors and Collaborators
Charite University, Berlin, Germany
Berlin Institute of Health
Investigators
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Principal Investigator: Philipp Enghard, PD Dr. med. Charite University, Berlin, Germany
Publications:

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Responsible Party: Philipp Enghard, PD Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04320797    
Other Study ID Numbers: SLEFLURINOCYTE
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philipp Enghard, Charite University, Berlin, Germany:
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
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases