Telitacicept for IgA nephropathy — interim Analysis of a phase 3 trial (Registro nro. 22903)
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| 000 -Cabecera | |
|---|---|
| Campo de control interno | 02955nam a2200313 4500 |
| 001 - Número de control | |
| control field | ESSALUD |
| 005 - Fecha y hora de la última transacción | |
| Campo de control | 20260902161050.0 |
| 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 | eng |
| 100 ## - Autor | |
| Autor | Lv, Jicheng |
| 9 (RLIN) | 54473 |
| 245 ## - Titulo | |
| Titulo | Telitacicept for IgA nephropathy — interim Analysis of a phase 3 trial |
| 300 ## - Páginas | |
| Paginación | páginas: 1916-1924 |
| 520 ## - Resumen | |
| Resumen | Background: The pathogenesis of IgA nephropathy is mediated by B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Telitacicept is a fusion protein that targets and neutralizes both BAFF and APRIL and, as such, might be effective in IgA nephropathy. Methods: We now report a prespecified interim analysis of a phase 3, multicenter, double-blind, randomized, placebo-controlled trial, which enrolled adults with biopsy-proven IgA nephropathy and persistent proteinuria (protein level, ≥1.0 g per day), despite appropriate supportive care. Patients were randomly assigned in a 1:1 ratio to receive subcutaneous once-weekly telitacicept (240 mg) or matching placebo. The primary end point was the geometric mean ratio of the 24-hour urinary protein-to-creatinine ratio at 39 weeks relative to baseline. Safety was also evaluated. Results: A total of 318 patients were assigned to receive telitacicept or placebo (159 in each group). At week 39, the percentage change in the 24-hour urinary protein-to-creatinine ratio was −58.9% with telitacicept and −8.8% with placebo, which corresponded to a relative difference (based on the ratio of geometric mean reductions between the two groups) of −55.0% (95% confidence interval [CI], −61.3 to −47.6; P<0.001) in favor of active medication. The percentage change in the estimated glomerular filtration rate relative to baseline was −1.0% (95% CI, −3.2 to 1.2) with telitacicept and −7.7% (95% CI, −9.9 to −5.4) with placebo. Adverse events were more common with telitacicept than with placebo (in 89.3% vs. 78.6% of patients), although serious adverse events were less common (in 2.5% vs. 8.2%). No unexpected safety findings were reported with telitacicept. Conclusions: In patients with IgA nephropathy at high risk for progression, 39 weeks of treatment with telitacicept led to a greater reduction in the 24-hour urinary protein-to-creatinine ratio than placebo. |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ENFERMEDAD RENAL CRÓNICA |
| 9 (RLIN) | 32213 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | MEDICINA CLÍNICA GENERAL |
| 9 (RLIN) | 53666 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | ENFERMEDAD GLOMERULAR |
| 9 (RLIN) | 54474 |
| 650 ## - Temas - Descriptores | |
| Temas - Descriptores | NEFROLOGÍA GENERAL |
| 9 (RLIN) | 53655 |
| 700 ## - Autor Personal | |
| Autor Personal | Liu, Lijun |
| 9 (RLIN) | 54475 |
| 700 ## - Autor Personal | |
| Autor Personal | Wang, Wenxiang |
| 9 (RLIN) | 54476 |
| 700 ## - Autor Personal | |
| Autor Personal | Wang, Xinyue |
| 9 (RLIN) | 54477 |
| 700 ## - Autor Personal | |
| Autor Personal | Zuraw, Qing |
| 9 (RLIN) | 54478 |
| 700 ## - Autor Personal | |
| Autor Personal | Perkovic, Vlado |
| 9 (RLIN) | 54479 |
| 700 ## - Autor Personal | |
| Autor Personal | Fang, Jianmin |
| 9 (RLIN) | 54480 |
| 700 ## - Autor Personal | |
| Autor Personal | Zhang, Hong |
| 9 (RLIN) | 54481 |
| 773 0# - Revista (Relacion con el numero) | |
| Host Biblionumber | 22717 |
| Host Itemnumber | 22669 |
| Ciudad, Editorial | Massachusetts NEJM Group |
| Codigo barras item/ejemplar | NEJM014 |
| 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 | 2026-08-31 |
| Catalogador | sqb |
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