Weaning of Immunosuppression in Nephritis of Lupus

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Weaning of Immunosuppression in Nephritis of Lupus

Conditions
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Nephritis of Lupus

Intervention / Treatment
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* Drug: mycophenolate mofetil or azathioprine
* Other: immunosuppressive treatment discontinuation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immunosuppressive treatment discontinuation,<br> | Other: immunosuppressive treatment discontinuation<br> <br> |
| Active Comparator: Continuation of immunosuppressive therapy<br>with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids | Drug: mycophenolate mofetil or azathioprine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |