Weaning of Immunosuppression in Nephritis of Lupus (WIN-Lupus)
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.
Nephritis of Lupus
Drug: mycophenolate mofetil or azathioprine
Other: immunosuppressive treatment discontinuation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Weaning of Immunosuppression in Nephritis of Lupus|
- discontinuation of maintenance immunosuppressive therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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
- compare 2 therapeutic strategies [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: immunosuppressive treatment discontinuation,||Other: immunosuppressive treatment discontinuation|
Active Comparator: Continuation of immunosuppressive therapy
with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids
|Drug: mycophenolate mofetil or azathioprine|
open multicenter randomized non-inferiority study, comparing 2 types of therapeutic strategies after 2 years of maintenance treatment:
- Group I: Continuation of immunosuppressive therapy with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids.
- Group II: immunosuppressive treatment discontinuation, continuation of hydroxychloroquine, and possibly low-dose corticosteroids (15 mg / day).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284725
|Contact: NOEMIE JOURDE CHICHE||Noemie.Jourde@ap-hm.fr|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: NOEMIE JOURDE CHICHE email@example.com|
|Principal Investigator: Noémie Jourde chiche|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|
|Principal Investigator:||NOEMIE JOURDE CHICHE||Assistance publique Hôpitaux de marseille|