Weaning of Immunosuppression in Nephritis of Lupus (WIN-Lupus)
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|ClinicalTrials.gov Identifier: NCT01284725|
Recruitment Status : Unknown
Verified April 2013 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : January 27, 2011
Last Update Posted : September 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Nephritis of Lupus||Drug: mycophenolate mofetil or azathioprine Other: immunosuppressive treatment discontinuation||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weaning of Immunosuppression in Nephritis of Lupus|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||August 2017|
|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
- discontinuation of maintenance immunosuppressive therapy [ Time Frame: 2 years ]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 ]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.
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): 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|