Weaning of Immunosuppression in Nephritis of Lupus
- Conditions
- Nephritis of Lupus
- Interventions
- Other: immunosuppressive treatment discontinuation
- Registration Number
- NCT01284725
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description immunosuppressive treatment discontinuation, immunosuppressive treatment discontinuation - Continuation of immunosuppressive therapy mycophenolate mofetil or azathioprine with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Assistance Publique Hopitaux de Marseille
🇫🇷Marseille, France