Clinical Trial Treatment in Lupus Nephritis (Csa-LES)

Phase III, Open, Randomized, Parallel-group Clinical Trial, to Evaluate the Efficacy and Safety of Treatment With Prednisone, Cyclosporine, Mycophenolic Acid Versus Prednisone and Mycophenolic Acid in Lupus Nephritis Type III-IV-V.

Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon, Hospital Universitario Ramon y Cajal, Hospital Infanta Sofia, Hospital Universitario Infanta Leonor, Hospital Universitario Reina Sofia de Cordoba, Hospital Regional Universitario Carlos Haya, Hospital Universitario Virgen de la Victoria, University Hospital of the Nuestra Señora de Candelaria, Hospital Universitario de Guadalajara. Spain, Hospital San Pedro de Alcantara, Hospital Juan Canalejo

The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in both the induction and maintenance with similar results at least to those offered by the classic pattern and possibly with fewer side effects, especially for long term. The association of prednison and mycophenolate has created large expectations to that effect, and is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V. Despite the significant advances that have led to these treatments, the likelihood of complete remission after six months remains, according to the series of 8-13% and partial remission do not exceed 60% in papers published. In the last year, two articles have been published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in poor prognosis of lupus nephritis with hopefully better results than those obtained previously. In this study we try to compare the effectiveness of triple therapy, the therapy is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type III-IV-V

the number of complete remissions, between the triple therapy with cyclosporine-prednisone-mycophenolic acid and conventional therapy with mycophenolic acid-prednisone as induction therapy in patients with lupus nephritis type III-IV-V

the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.

Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal

Inclusion Criteria: Age > 18 years old Patients diagnosed SLE with renal type III-IV-V confirmed by renal biopsy done in the last 6 months Proteinuria > 2 g/24 hours and hematuria (> 5 h / field) MDRD4 eGFR > 60 ml/min/1.73m2 Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: Central nervous system LES involvement or any other vital organ Active infection Use of mycophenolic acid, mycophenolate mofetil, cyclosporine or tacrolimus in the last 6 months No adherence Women of childbearing age not using appropriate contraceptive methods. Positive pregnancy test Anasarca Malignancy or cancer history (except basal cell skin carcinomas) Patient participating in another study with an investigational drug or have participated within 28 days prior to entry into this study