Clinical Trial Treatment in Lupus Nephritis

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

Conditions

• Lupus Nephritis

Interventions

DRUG

cyclosporine +mycophenolic acid+prednison

Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks

DRUG

Mycophenolic Acid + prednison

Mycophenolic Acid + prednison for 106 weeks

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Infanta Sofia

  collaborator OTHER

• Hospital Universitario Infanta Leonor

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Hospital Regional Universitario Carlos Haya

  collaborator OTHER

• Hospital Universitario Virgen de la Victoria

  collaborator OTHER

• University Hospital of the Nuestra Señora de Candelaria

  collaborator OTHER

• Hospital Universitario de Guadalajara. Spain

  collaborator UNKNOWN

• Hospital San Pedro de Alcantara

  collaborator OTHER

• Hospital Juan Canalejo

  collaborator OTHER

• Hospital Universitario Fundación Alcorcón

  lead OTHER

Principal Investigators

• Fernandez Juarez Gema, MD Ph · Hospital Universitario Fundación Alcorcón

• Praga Terente Manuel, MD Ph · Hospital Universitario Doce de Octubre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2014-03-31

Completion

2014-10-31

Countries

• Spain

Study Locations