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

February 25, 2021 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
discontinuation of maintenance immunosuppressive therapy
Time Frame: 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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare 2 therapeutic strategies
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: NOEMIE JOURDE CHICHE, Assistance Publique Hopitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

January 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-022859-30
  • 2010-15 (AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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