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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-15 | Other Identifier | AP HM |
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The investigators wish to evaluate the discontinuation of maintenance immunosuppressive treatment after 2 years in patients with stable remission after a proliferative lupus nephritis. The patients will be continuing their treatment with hydroxychloroquine, possibly associated with low dose corticosteroids.
open multicenter randomized non-inferiority study, comparing 2 types of therapeutic strategies after 2 years of maintenance treatment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunosuppressive treatment discontinuation, | Experimental |
| |
| Continuation of immunosuppressive therapy | Active Comparator | with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil or azathioprine | Drug |
| ||
| immunosuppressive treatment discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| discontinuation of maintenance immunosuppressive therapy | to demonstrate that discontinuation of maintenance immunosuppressive therapy does not expose patients to a greater risk of relapse of proliferative lupus nephritis compared to the continuation of this treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| compare 2 therapeutic strategies | to compare 2 therapeutic strategies in terms of relapse-free survival, overall survival , cumulative rate of 'relapse and / or death ', rates of adverse events , evolution of renal function , activity of SLE , consumption of steroids, impact on quality of life and economic impact. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille | Study Director |
| NOEMIE JOURDE CHICHE | Assistance publique Hôpitaux de marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38942591 | Background | Himbert M, Jourde-Chiche N, Chapart L, Charles N, Baumstarck K, Daugas E. Anti-dsDNA IgE: a potential non-invasive test for prediction of lupus nephritis relapse. RMD Open. 2024 Jun 28;10(2):e004255. doi: 10.1136/rmdopen-2024-004255. | |
| 37547513 | Background | Jourde-Chiche N, Bobot M, Burtey S, Chiche L, Daugas E. Weaning Maintenance Therapy in Lupus Nephritis: For Whom, When, and How? Kidney Int Rep. 2023 May 22;8(8):1481-1488. doi: 10.1016/j.ekir.2023.05.012. eCollection 2023 Aug. |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Other |
|
| 38301681 | Background | Jourde-Chiche N, Chiche L. An era of immunosuppressant withdrawal in systemic lupus erythematosus: winning through weaning. Lancet Rheumatol. 2024 Mar;6(3):e133-e134. doi: 10.1016/S2665-9913(24)00001-8. Epub 2024 Jan 29. No abstract available. |
| 36566116 | Background | Chiche L, Jousse-Joulin S, Jourde-Chiche N. [From "Treat to Target" to "Think to Untreat": Therapeutic de-implementation as a new paradigm in systemic lupus erythematosus]. Rev Med Interne. 2023 Mar;44(3):101-104. doi: 10.1016/j.revmed.2022.12.001. Epub 2022 Dec 22. No abstract available. French. |
| 35725295 | Result | Jourde-Chiche N, Costedoat-Chalumeau N, Baumstarck K, Loundou A, Bouillet L, Burtey S, Caudwell V, Chiche L, Couzi L, Daniel L, Deligny C, Dussol B, Faguer S, Gobert P, Gondran G, Huart A, Hummel A, Kalbacher E, Karras A, Lambert M, Le Guern V, Lebourg L, Loubiere S, Maillard-Lefebvre H, Maurier F, Pha M, Queyrel V, Remy P, Sarrot-Reynauld F, Verhelst D, Hachulla E, Amoura Z, Daugas E; WIN-Lupus study group. Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial. Ann Rheum Dis. 2022 Oct;81(10):1420-1427. doi: 10.1136/annrheumdis-2022-222435. Epub 2022 Jun 20. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |