Iptacopan in IgA nephropathy — Final 24-month data (Registro nro. 22753)
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| 000 -Cabecera | |
|---|---|
| Campo de control interno | 03217nam a2200301 4500 |
| 001 - Número de control | |
| control field | ESSALUD |
| 007 - Tipo material - Descripcion fisica - info general | |
| Tipo material - Descripcion fisica - info general | ta |
| 008 - Elementos de Longitud Fija - Información General | |
| Elementos de Longitud Fija - Información | t pe ||||| |||| 00| 0 spa d |
| 040 ## - Origen de la Catalogación | |
| Origen de la Catalogación | BMG |
| 041 ## - Idioma | |
| Idioma | spa |
| 100 ## - Autor | |
| Autor | Barratt, Jonathan |
| 9 (RLIN) | 53827 |
| 245 ## - Titulo | |
| Titulo | Iptacopan in IgA nephropathy — Final 24-month data |
| 300 ## - Páginas | |
| Paginación | páginas: 465-477 |
| 520 ## - Resumen | |
| Resumen | Background: Overactivation of the alternative complement pathway contributes to IgA nephropathy and glomerular inflammation. In the 9-month interim analysis of this phase 3 trial, iptacopan, a complement factor B inhibitor, led to a significant reduction of 38.3% in the 24-hour urinary protein-to-creatinine ratio as compared with placebo and had an acceptable safety profile.<br/>Methods: In this phase 3 trial, we enrolled adults who had IgA nephropathy, an estimated glomerular filtration rate (eGFR) of at least 30 ml per minute per 1.73 m2 of body-surface area, and a 24-hour urinary protein-to-creatinine ratio of 1 or higher (with protein and creatinine both measured in grams) despite supportive care. Patients were randomly assigned, in a 1:1 ratio, to receive oral iptacopan (200 mg) or placebo twice daily. The primary end point for the final analysis was the annualized total eGFR slope as estimated over a 24-month period. Secondary end points included a composite kidney-failure end point (i.e., a sustained decline in eGFR of ≥30%, a sustained eGFR of <15 ml per minute per 1.73 m2, the initiation of maintenance dialysis, receipt of kidney transplant, or death from kidney failure), assessed in a time-to-event analysis. Safety was also assessed.<br/>Results: Among 477 patients included in the final analysis, 238 had been randomly assigned to iptacopan and 239 to placebo. The annualized total eGFR slope was −3.10 ml per minute per 1.73 m2 per year with iptacopan, as compared with −6.12 ml per minute per 1.73 m2 per year with placebo (difference, 3.02 ml per minute per 1.73 m2 per year; 95% confidence interval [CI], 2.02 to 4.01; adjusted P<0.001). A composite kidney-failure end-point event occurred in 21.4% of the patients in the iptacopan group, as compared with 33.5% of those in the placebo group (hazard ratio, 0.57; 95% CI, 0.40 to 0.81; adjusted P=0.003). The incidence of adverse events was 87.0% in the iptacopan group and 89.1% in the placebo group. Serious adverse events occurred in 12.2% of the patients who received iptacopan and in 11.7% of those who received placebo, and serious infections in 6.7% and 2.1%, respectively. No deaths occurred.<br/>Conclusions: Iptacopan therapy led to a significantly slower decline in kidney function than placebo |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ALERGIA |
| 9 (RLIN) | 7055 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | INMUNOLOGÍA |
| 9 (RLIN) | 34121 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ENFERMEDAD RENAL CRÓNICA |
| 9 (RLIN) | 32213 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | MEDICINA CLÍNICA |
| 9 (RLIN) | 33681 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | GASTROENTEROLOGÍA |
| 9 (RLIN) | 12562 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | NEFROLOGÍA |
| 9 (RLIN) | 13133 |
| 700 ## - Autor Personal | |
| Autor Personal | Eren, Necmi |
| 9 (RLIN) | 53828 |
| 700 ## - Autor Personal | |
| Autor Personal | Kashihara, Naoki |
| 9 (RLIN) | 53829 |
| 700 ## - Autor Personal | |
| Autor Personal | Maes, Bart |
| 9 (RLIN) | 53830 |
| 700 ## - Autor Personal | |
| Autor Personal | Rizk, Dana V. |
| 9 (RLIN) | 53831 |
| 700 ## - Autor Personal | |
| Autor Personal | Rovin, Brad |
| 9 (RLIN) | 53832 |
| 773 0# - Revista (Relacion con el numero) | |
| Host Biblionumber | 22717 |
| Host Itemnumber | 22638 |
| Ciudad, Editorial | Massachusetts NEJM Group |
| Codigo barras item/ejemplar | NEJM005 |
| Titulo de la Revista | The New England Journal of Medicine |
| Número de control de registro | ESSALUD |
| ISSN | 0028-4793 |
| 942 ## - Elementos de Koha | |
| Tipo de Documento | Artículos |
| Fecha procesamiento | 2026-07-31 |
| Catalogador | SQB |
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