Clinical trial NCT01299922: Clinical Trial Treatment in Lupus Nephritis
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 Lupus Nephritis Type III-IV-V.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: Lupus nephritis
Therapy
Cyclosporin
Mycophenolic acid
Lead sponsor: Hospital Universitario Fundación Alcorcón
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario Ramon y Cajal
name: Hospital Infanta Sofia
name: Hospital Universitario Infanta Leonor
name: Hospital Universitario Reina Sofia de Cordoba
name: Hospital Regional Universitario Carlos Haya
name: Hospital Universitario Virgen de la Victoria
name: University Hospital of the Nuestra Señora de Candelaria
name: Hospital Universitario de Guadalajara. Spain
name: Hospital San Pedro de Alcantara
name: Hospital Juan Canalejo
First posted: 2011-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: asd

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 36 months
Secondary outcomes:
measure: the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.
timeFrame: 36 months
measure: the number of patients with adverse effects
timeFrame: 36 months
measure: the rate (%) of decline of proteinuria in two groups
timeFrame: 36 months
measure: the decrease in GFR (ml/min/1.73m2) in both groups
timeFrame: 36 months
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
Study officials:
affiliation: Hospital Universitario Fundación Alcorcón
name: Fernandez Juarez Gema, MD Ph
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Doce de Octubre
name: Praga Terente Manuel, MD Ph
role: STUDY_CHAIR
References: