Nephritis of Lupus
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGmycophenolate mofetil or azathioprine
OTHERimmunosuppressive treatment discontinuation
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18-years-old patient, woman or man, * Patient having a lupus according to the criteria of the ACR, * Patient having presented a glomérulonéphrite lupique proliférative (class III or IV Has +/-C, +/-list(classify) V) - first push or relapse - proved by renal biopsy, * Patient having received for this push a treatment of attack by steroids with strong doses and cyclophosphamide or mycophénolate mofétil, * Patient in the course of treatment of interview(maintenance) by azathioprine or mycophénolate mofétil for at least 2 years, and at most for 3 years, with at the time of the inclusion, mycophénolate mofétil? 1 gram / day or azathioprine? 50 in the daytime, * Patient in reply renal complete or partial (criteria of the European, secondary consensus 2) since? 12 months, * Patient under Plaquenil ® since? 6 months with a hydroxychloroquinémie = 750 µg / L, * Patient having accepted of participated in the study and having signed a lit(enlightened) consent.
Exclusion criteria
* Patient presenting a severe chronic renal insufficiency (DFG estimated(esteemed) by MDRD \< 30 ml / min / 1.73m ²), * Patient having presented an extra-renal push having required an increase of corticoids à\> 20 in the daytime during at least 7 days less than 6 months ago, * Patient presenting a contraindication to the hydroxychloroquine, * Unaffiliated patient in a national social security, * Minor patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| discontinuation of maintenance immunosuppressive therapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compare 2 therapeutic strategies | 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. |
Countries
France
Outcome results
None listed