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| Name | Class |
|---|---|
| Hospital Universitario 12 de Octubre | OTHER |
| Hospital General Universitario Gregorio MaraƱon | OTHER |
| Hospital Universitario Ramon y Cajal | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclosporine+mycophenolic acid+prednison | Experimental | Triple therapy |
|
| mycophenolic acid + prednison | Active Comparator | Mycophenolic acid+prednison 106 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine +mycophenolic acid+prednison | Drug | Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks |
|
| 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:
| 36 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernandez Juarez Gema, MD Ph | Hospital Universitario Fundación Alcorcón | Study Director |
| Praga Terente Manuel, MD Ph | Hospital Universitario Doce de Octubre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid | 28922 | Spain |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 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 SeƱora de Candelaria | OTHER |
| University of Guadalajara | OTHER |
| Hospital San Pedro de Alcantara | OTHER |
| Hospital Juan Canalejo | OTHER |
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| Mycophenolic Acid + prednison | Drug | Mycophenolic Acid + prednison for 106 weeks |
|
|
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |