Clinical Trial: Clinical Trial Treatment in Lupus Nephritis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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

Brief 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 Summary: asd
Sponsor: Hospital Universitario Fundación Alcorcón

Current Primary Outcome: 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 [ Time Frame: 36 months ]

Complete remission:

  • Proteinuria < 0.3 g/24h
  • Albumin normal
  • eGFR > 60 mL/min/1.73 m2


Original Primary Outcome: Complete remission: - Proteinuria < 0.3 g/24h - Albumin normal - eGFR > 60 mL/min/1.73 m2 [ Time Frame: 36 months ]

To compare the efficacy, defined as 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


Current Secondary Outcome:

  • the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid. [ Time Frame: 36 months ]
    Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal
  • the number of patients with adverse effects [ Time Frame: 36 months ]
  • the rate (%) of decline of proteinuria in two groups [ Time Frame: 36 months ]
  • the decrease in GFR (ml/min/1.73m2) in both groups [ Time Frame: 36 months ]


Original Secondary Outcome:

  • Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal [ Time Frame: 36 months ]
    To compare the efficacy, defined as the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.
  • To Analyze the safety and tolerance in the two groups [ Time Frame: 36 months ]
    Analyze the number of patients with adverse effects
  • To Compare the development of proteinuria in two groups [ Time Frame: 36 months ]
    To compare the rate (%) of decline of proteinuria in two groups
  • To compare the renal evolution in two groups [ Time Frame: 36 months ]
    To Compare the decrease in GFR (ml/min/1.73m2) in both groups


Information By: Hospital Universitario Fundación Alcorcón

Dates:
Date Received: February 18, 2011
Date Started: February 2011
Date Completion: October 2014
Last Updated: February 26, 2015
Last Verified: February 2011