Weaning of Immunosuppression in Nephritis of Lupus (WIN-Lupus)

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Completed

Phase 3

Conditions

Nephritis of Lupus

Treatments

Other: immunosuppressive treatment discontinuation

Drug: mycophenolate mofetil or azathioprine

Study type

Interventional

Funder types

Other

Identifiers

NCT01284725

2010-15

2010-022859-30

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.