Clinical Trial Treatment in Lupus Nephritis

Study Overview
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Brief Summary
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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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Official Title
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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.

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: cyclosporine +mycophenolic acid+prednison
* Drug: Mycophenolic Acid + prednison


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cyclosporine+mycophenolic acid+prednison<br>Triple therapy | Drug: cyclosporine +mycophenolic acid+prednison<br>* Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks<br>* Other names: Triple therapy;|
| Active Comparator: mycophenolic acid + prednison<br>Mycophenolic acid+prednison 106 weeks | Drug: Mycophenolic Acid + prednison<br>* Mycophenolic Acid + prednison for 106 weeks<br>* Other names: Conventional therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Complete remission: Proteinuria < 0.3 g/24h Albumin normal eGFR > 60 mL/min/1.73 m2 | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid. | Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal | 36 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus nephritis, Therapy, Cyclosporin, Mycophenolic acid