Weaning of Immunosuppression in Nephritis of Lupus

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique Hopitaux De Marseille
• Treatments: Azathioprine; Immunosuppressive Agents; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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.