Weaning of Immunosuppression in Nephritis of Lupus

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT01284725
• Date of registration: 21/01/2011
• Prospective Registration: No
• Primary sponsor: Assistance Publique Hopitaux De Marseille
• Public title: Weaning of Immunosuppression in Nephritis of Lupus WIN-Lupus
• Scientific title: Weaning of Immunosuppression in Nephritis of Lupus
• Date of first enrolment: January 2011
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01284725
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: BERNARD BELAIGUES
• Affiliation: Assistance Publique hôpitaux de Marseille

• Name: NOEMIE JOURDE CHICHE
• Affiliation: Assistance publique Hôpitaux de marseille

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Nephritis of Lupus

Intervention(s)

Other: immunosuppressive treatment discontinuation

Drug: mycophenolate mofetil or azathioprine

Primary Outcome(s)

discontinuation of maintenance immunosuppressive therapy [Time Frame: 2 years]

Secondary Outcome(s)

compare 2 therapeutic strategies [Time Frame: 2 years]

Secondary ID(s)

2010-15

2010-022859-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors