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| Name | Class |
|---|---|
| Berlin Institute of Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active lupus nephritis | Patients with proliferative lupus nephritis (Class III and IV) |
| |
| Control | Patients with systemic lupus erythematodes without lupus nephritis or lupus nephritis I, II or VI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow cytometry analysis of urine samples | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at medical wards of Charité Universitätsmedizin Berlin and University College London
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Enghard, PD Dr. med. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany | |||
| The Royal Free London |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23475982 | Background | Enghard P, Rieder C, Kopetschke K, Klocke JR, Undeutsch R, Biesen R, Dragun D, Gollasch M, Schneider U, Aupperle K, Humrich JY, Hiepe F, Backhaus M, Radbruch AH, Burmester GR, Riemekasten G. Urinary CD4 T cells identify SLE patients with proliferative lupus nephritis and can be used to monitor treatment response. Ann Rheum Dis. 2014 Jan;73(1):277-83. doi: 10.1136/annrheumdis-2012-202784. Epub 2013 Mar 8. | |
| 31209404 |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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urine, lymphocytes
|
| 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 | 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. | 6 months |
| Diagnosis of proliferative lupus nephritis in patients with systemic lupus erythematodes (SLE) | Diagnosis according to initial T cell count | 6 months |
| London |
| NW3 2QG |
| United Kingdom |
| Background |
| Arazi A, Rao DA, Berthier CC, Davidson A, Liu Y, Hoover PJ, Chicoine A, Eisenhaure TM, Jonsson AH, Li S, Lieb DJ, Zhang F, Slowikowski K, Browne EP, Noma A, Sutherby D, Steelman S, Smilek DE, Tosta P, Apruzzese W, Massarotti E, Dall'Era M, Park M, Kamen DL, Furie RA, Payan-Schober F, Pendergraft WF 3rd, McInnis EA, Buyon JP, Petri MA, Putterman C, Kalunian KC, Woodle ES, Lederer JA, Hildeman DA, Nusbaum C, Raychaudhuri S, Kretzler M, Anolik JH, Brenner MB, Wofsy D, Hacohen N, Diamond B; Accelerating Medicines Partnership in SLE network. The immune cell landscape in kidneys of patients with lupus nephritis. Nat Immunol. 2019 Jul;20(7):902-914. doi: 10.1038/s41590-019-0398-x. Epub 2019 Jun 17. |
| 23445537 | Background | Dolff S, Abdulahad WH, Arends S, van Dijk MC, Limburg PC, Kallenberg CG, Bijl M. Urinary CD8+ T-cell counts discriminate between active and inactive lupus nephritis. Arthritis Res Ther. 2013 Feb 27;15(1):R36. doi: 10.1186/ar4189. |
| 25890061 | Background | Kopetschke K, Klocke J, Griessbach AS, Humrich JY, Biesen R, Dragun D, Burmester GR, Enghard P, Riemekasten G. The cellular signature of urinary immune cells in Lupus nephritis: new insights into potential biomarkers. Arthritis Res Ther. 2015 Apr 3;17(1):94. doi: 10.1186/s13075-015-0600-y. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |