Clinical Trial Treatment in Lupus Nephritis

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Fundación Alcorcón
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Infanta Sofia; Hospital Juan Canalejo; Hospital Regional Universitario Carlos Haya; Hospital San Pedro Alcantara. Caceres. Spain; Hospital San Pedro de Alcantara; Hospital Universitario 12 de Octubre; Hospital Universitario de Guadalajara. Spain; Hospital Universitario Infanta Leonor; Hospital Universitario Ramon y Cajal; Hospital Universitario Reina Sofia; Hospital Universitario Reina Sofia de Cordoba; Hospital Universitario Virgen de la Victoria; University Hospital of the Nuestra Señora de Candelaria
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Prednisone

Criteria

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