Weaning of Immunosuppression in Nephritis of Lupus

Nephritis of Lupus Clinical Trial

— WIN-Lupus  

Official title:

Weaning of Immunosuppression in Nephritis of Lupus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01284725
• Other study ID #: 2010-022859-30
• Secondary ID: 2010-15
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2011
• Est. completion date: August 2021

Study information

• Verified date: February 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nephritis
• Nephritis of Lupus

Intervention

Drug:
• mycophenolate mofetil or azathioprine

Other:
• immunosuppressive treatment discontinuation

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	discontinuation of maintenance immunosuppressive therapy	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	2 years
Secondary	compare 2 therapeutic strategies	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.	2 years