NCT01299922

Clinical Trial Treatment in Lupus Nephritis

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.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital Universitario Fundación Alcorcón · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	cyclosporine +mycophenolic acid+prednison	Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks
DRUG	Mycophenolic Acid + prednison	Mycophenolic Acid + prednison for 106 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-03-01
• Completion: 2014-10-01
• First posted: 2011-02-21
• Last updated: 2015-02-27

Locations

1 site across 1 country: Spain