Nephritis of Lupus Clinical Trial
— WIN-LupusOfficial title:
Weaning of Immunosuppression in Nephritis of Lupus
| Verified date | February 2021 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | August 2021 |
| Est. primary completion date | January 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 2 years | |
| Secondary | 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. | 2 years |