Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2011-02-28
2014-10-31
Brief Summary
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cyclosporine+mycophenolic acid+prednison
Triple therapy
cyclosporine +mycophenolic acid+prednison
Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks
mycophenolic acid + prednison
Mycophenolic acid+prednison 106 weeks
Mycophenolic Acid + prednison
Mycophenolic Acid + prednison for 106 weeks
Interventions
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cyclosporine +mycophenolic acid+prednison
Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks
Mycophenolic Acid + prednison
Mycophenolic Acid + prednison for 106 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospital Universitario 12 de Octubre
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Infanta Sofia
OTHER
Hospital Universitario Infanta Leonor
OTHER
Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Hospital Regional Universitario Carlos Haya
OTHER
Hospital Universitario Virgen de la Victoria
OTHER
University Hospital of the Nuestra Señora de Candelaria
OTHER
Hospital Universitario de Guadalajara. Spain
UNKNOWN
Hospital San Pedro de Alcantara
OTHER
Hospital Juan Canalejo
OTHER
Hospital Universitario Fundación Alcorcón
OTHER
Responsible Party
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Hospital Universitario Doce de Octubre Madrid Spain
Principal Investigators
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Fernandez Juarez Gema, MD Ph
Role: STUDY_DIRECTOR
Hospital Universitario Fundación Alcorcón
Praga Terente Manuel, MD Ph
Role: STUDY_CHAIR
Hospital Universitario Doce de Octubre
Locations
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Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Countries
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Other Identifiers
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Csa-LES
Identifier Type: -
Identifier Source: org_study_id