Clinical trial NCT01284725: Weaning of Immunosuppression in Nephritis of Lupus
Official title: Weaning of Immunosuppression in Nephritis of Lupus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nephritis of Lupus
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: discontinuation of maintenance immunosuppressive therapy
timeFrame: 2 years
Secondary outcomes:
measure: compare 2 therapeutic strategies
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
affiliation: Assistance publique Hôpitaux de marseille
name: NOEMIE JOURDE CHICHE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jourde-Chiche N, Costedoat-Chalumeau N, Baumstarck K, Loundou A, Bouillet L, Burtey S, Caudwell V, Chiche L, Couzi L, Daniel L, Deligny C, Dussol B, Faguer S, Gobert P, Gondran G, Huart A, Hummel A, Kalbacher E, Karras A, Lambert M, Le Guern V, Lebourg L, Loubiere S, Maillard-Lefebvre H, Maurier F, Pha M, Queyrel V, Remy P, Sarrot-Reynauld F, Verhelst D, Hachulla E, Amoura Z, Daugas E; WIN-Lupus study group. Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial. Ann Rheum Dis. 2022 Oct;81(10):1420-1427. doi: 10.1136/annrheumdis-2022-222435. Epub 2022 Jun 20.