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

Primary Purpose

Nephritis of Lupus

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
mycophenolate mofetil or azathioprine
immunosuppressive treatment discontinuation
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephritis of Lupus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

immunosuppressive treatment discontinuation,

Continuation of immunosuppressive therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 21, 2011
Last Updated
February 25, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01284725
Brief Title
Weaning of Immunosuppression in Nephritis of Lupus
Acronym
WIN-Lupus
Official Title
Weaning of Immunosuppression in Nephritis of Lupus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephritis of Lupus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immunosuppressive treatment discontinuation,
Arm Type
Experimental
Arm Title
Continuation of immunosuppressive therapy
Arm Type
Active Comparator
Arm Description
with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil or azathioprine
Intervention Type
Other
Intervention Name(s)
immunosuppressive treatment discontinuation
Primary Outcome Measure Information:
Title
discontinuation of maintenance immunosuppressive therapy
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
compare 2 therapeutic strategies
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
NOEMIE JOURDE CHICHE
Organizational Affiliation
Assistance publique Hôpitaux de marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35725295
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.
Results Reference
derived

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Weaning of Immunosuppression in Nephritis of Lupus

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