Clinical Trial Treatment in Lupus Nephritis
- Conditions
- Lupus Nephritis
- Interventions
- Drug: Mycophenolic Acid + prednison
- Registration Number
- NCT01299922
- Lead Sponsor
- Hospital Universitario Fundación Alcorcón
- 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
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Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cyclosporine+mycophenolic acid+prednison cyclosporine +mycophenolic acid+prednison Triple therapy mycophenolic acid + prednison Mycophenolic Acid + prednison Mycophenolic acid+prednison 106 weeks
- Primary Outcome Measures
Name Time Method 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 36 months Complete remission:
* Proteinuria \< 0.3 g/24h
* Albumin normal
* eGFR \> 60 mL/min/1.73 m2
- Secondary Outcome Measures
Name Time Method the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid. 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 36 months the rate (%) of decline of proteinuria in two groups 36 months the decrease in GFR (ml/min/1.73m2) in both groups 36 months
Trial Locations
- Locations (1)
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcon, Madrid, Spain