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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284725
First received: January 21, 2011
Last updated: August 29, 2014
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weaning of Immunosuppression in Nephritis of Lupus

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • discontinuation of maintenance immunosuppressive therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284725

Contacts
Contact: NOEMIE JOURDE CHICHE Noemie.Jourde@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: NOEMIE JOURDE CHICHE       noemie.jourde@ap-hm.fr   
Principal Investigator: Noémie Jourde chiche         
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
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01284725     History of Changes
Other Study ID Numbers: 2010-022859-30, 2010-15
Study First Received: January 21, 2011
Last Updated: August 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Nephritis
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Mycophenolate mofetil
Azathioprine
Immunosuppressive Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Antimetabolites, Antineoplastic
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014