WIN-Lupus: Weaning of Immunosuppression in Nephritis of Lupus

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01284725

Collaborator

(none)

100

Enrollment

Location

Arms

127

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephritis of Lupus	Drug: mycophenolate mofetil or azathioprine Other: immunosuppressive treatment discontinuation	Phase 3

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Weaning of Immunosuppression in Nephritis of Lupus

Actual Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: immunosuppressive treatment discontinuation,

Other: immunosuppressive treatment discontinuation

Active Comparator: Continuation of immunosuppressive therapy

with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids

Drug: mycophenolate mofetil or azathioprine

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: BERNARD BELAIGUES, Assistance Publique hôpitaux de Marseille
Principal Investigator: NOEMIE JOURDE CHICHE, Assistance publique Hôpitaux de marseille