Trial | NCT01299922  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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
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Study Started
Feb 28
2011
Primary Completion
Mar 31
2014
Anticipated
Study Completion
Oct 31
2014
Anticipated
Last Update
Feb 27
2015
Estimate

Drug cyclosporine +mycophenolic acid+prednison

Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks

  • Other names: Triple therapy

Drug Mycophenolic Acid + prednison

Mycophenolic Acid + prednison for 106 weeks

  • Other names: Conventional therapy

cyclosporine+mycophenolic acid+prednison Experimental

Triple therapy

mycophenolic acid + prednison Active Comparator

Mycophenolic acid+prednison 106 weeks

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
No Results Posted