Weaning of Immunosuppression in Nephritis of Lupus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-16

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Nephritis of Lupus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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immunosuppressive treatment discontinuation,

Group Type EXPERIMENTAL

immunosuppressive treatment discontinuation

Intervention Type OTHER

Continuation of immunosuppressive therapy

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

Group Type ACTIVE_COMPARATOR

mycophenolate mofetil or azathioprine

Intervention Type DRUG

Interventions

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mycophenolate mofetil or azathioprine

Intervention Type DRUG

immunosuppressive treatment discontinuation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No