- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02889575
Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery (PIIINP-NGAL)
Prospective Multicenter Study to Assess the Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery During Acute Tubular Necrosis
Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular filtration rate decreasing. Acute Tubular Necrosis (ATN) remain the major cause of ARF involving distress and destruction of tubular cells. This specific typology of ARF may evolve toward Chronic Renal Failure (CRF) concretizing a major public health issue.
Predict the progression of ARF towards CRF appears essential. The investigators believe that the PIIINP and urinary NGAL biomarkers may constitute robust biomarkers of progression risk towards CRF.
Descripción general del estudio
Estado
Descripción detallada
Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular filtration rate decreasing. Beside its frequency, ARF may be associated with severe prognostic. Thus, patient admitted in ICU and suffering of ARF requiring dialysis, had a higher risk of mortality up to 50%.
Tubulointerstitial nephropathies, particularly Acute Tubular Necrosis (ATN) remain the major cause of ARF, representing 45-50% of cases. The ATN is due to suffering and destruction of tubular cells which are very sensitive to ischemia-reperfusion lesions because tubular reabsorption functions require significant and constant energy intake. However, ATN represents a relatively homogeneous group in terms of acute kidney disease typology. Homogeneity and significant frequency compels ATN as an optimal model to study function recovery after ARF.
ARF constitutes a major public health issue. Actually, incidence of Chronic Renal Failure (CRF) after an ARF, due to ATN, is estimated between 19% and 31%. In addition 12.5% of patients with specific ARF presentation immediately reach End-stage Renal Disease (ESRD), and the occurrence of ARF requiring dialysis, triples the risk of chronic renal support.
Therefore, predict the progression of ARF towards CRF appears essential.
At this time, the investigators currently lack of reliable biomarkers to predict such progression. This pejorative kidney development is due to the persistence of intrarenal inflammation, rapid development of interstitial fibrosis and deficiency in tubular restoration. It involves complex mechanisms of inflammatory response, and vascular and tubular remodeling.
Two promising biomarkers of renal fibrosis, ARF occurrence and CRF progression risk appear in recent years: the Procollagen III N-terminal peptide (PIIINP) and the neutrophil gelatinase associated lipocalin (NGAL). The investigators believe that the PIIINP and urinary NGAL may constitute robust biomarkers of progression (or not) towards CRF in ARF context. Firstly, PIIINP is a good reflection of fibrosis process inside the kidney. Secondarily, NGAL is a marker of renal tubule remodeling after renal aggression. The combination of these two biomarkers could therefore efficiently reflect the balance tubular fibrosis/restoration and may allow optimal prediction of renal function recovery.
The investigators hypothesize that these two biomarkers may be used to assess the risk of CRF progression during ARF in ATN context.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- off-age patient.
- ATN diagnosis based on 1) typical clinical environment (sepsis, nephrotoxicity...) 2) 50% decrease of glomerular filtration flow (according clearance MDRD) or more than 100micromol plasmatic creatinine increase. 3) no renal function improvement after efficient vascular filling (>750cc normal saline or equivalent).
- Consent.
Exclusion Criteria:
- ARF not related with ATN context.
- Life expectancy less than 3 months.
- Protocol refusal
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PIIINP/Urinary Creatinine ratio levels between patients experimenting CRF or not.
Periodo de tiempo: 12months after initial diagnosis.
|
We expect to highlight different ratio PIIINP/Urinary Creatinine levels and evolution between patients experimenting CRF or not (defined less than 60 mL/min according MDRD formula).
|
12months after initial diagnosis.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
NGAL/Urinary Creatinine ratio levels between patients experimenting CRF or not.
Periodo de tiempo: 12, 18 and 24 months after initial diagnosis.
|
We expect to highlight different ratio NGAL/Urinary Creatinine levels and evolution between patients experimenting CRF or not (defined less than 60 mL/min according MDRD formula).
|
12, 18 and 24 months after initial diagnosis.
|
Correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.
Periodo de tiempo: 3, 6, 12, 18 or 24 months after initial diagnosis.
|
We expect to highlight linear correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.
|
3, 6, 12, 18 or 24 months after initial diagnosis.
|
Validation of high diagnostic performance of NGAL/Urinary Creatinine ratio to predict CRF occurrence.
Periodo de tiempo: 3, 6, 12, 18 or 24 months after initial diagnosis.
|
Sensitivity of NGAL/Urinary Creatinine ratio will be assessed at each time frame.
|
3, 6, 12, 18 or 24 months after initial diagnosis.
|
Validation of high diagnostic performance of PIIINP/Urinary Creatinine to predict CRF occurrence.
Periodo de tiempo: 3, 6, 12, 18 or 24 months after initial diagnosis.
|
Sensitivity of PIIINP/Urinary Creatinine ratio will be assessed at each time frame.
|
3, 6, 12, 18 or 24 months after initial diagnosis.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PROG/11/59
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Fallo renal agudo
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and Kidney... y otros colaboradoresReclutamientoEnfermedades Renales Crónicas | Fallo renal agudo | Lesión renal aguda | Insuficiencia Renal Aguda | Insuficiencia renal cronica | Insuficiencia Renal, Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia renal aguda | Insuficiencia Renal Crónica | Enfermedades... y otras condicionesEstados Unidos
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillTerminadoEnfermedades Renales Crónicas | Enfermedad Renal Crónica Etapa 5 | Enfermedad Renal Crónica etapa 4 | Enfermedad renal pediátrica | Enfermedad Renal Crónica etapa 3 | Enfermedad Renal Crónica Etapa V | Enfermedad renal crónica, estadio IV (grave) | Enfermedad Renal Crónica Etapa 2 | Enfermedad Renal...Estados Unidos
-
University Hospital, BordeauxMinistry of Health, FranceTerminadoTrasplante Renal | Enfermedad renal crónica en etapa terminal | Insuficiencia Renal Aguda SeveraFrancia
-
Wake Forest University Health SciencesStanford UniversityTerminadoTrasplante Renal | Rechazo Renal Agudo | Rechazo Renal Crónico | Rechazo de Trasplante Renal | Sistema Renina-AngiotensinaEstados Unidos
-
Faculdade de Ciências Médicas da Santa Casa de...TerminadoEnfermedad Renal Crónica | Diálisis renalBrasil
-
Outset MedicalTerminadoLesión renal aguda | Enfermedad renal en etapa terminal (ESRD) | Enfermedad renal en etapa terminal en diálisisEstados Unidos
-
Novartis PharmaceuticalsTerminadoHemodiálisis | Terapia de reemplazo renal | Enfermedad renal en etapa terminal (ESRD) | Trasplante Renal | Enfermedad renal crónica (ERC)Alemania, Estados Unidos, Bélgica, Italia, España, Croacia, Taiwán, Australia, Austria, Grecia, Corea, república de, Líbano, Chequia, Israel, Países Bajos, Eslovenia, Suiza, Tailandia, Noruega, Pavo, Suecia, Argentina, Brasil, Japón, Serbia, Federación Rusa y más
-
ArdelyxAstraZenecaTerminadoEnfermedad renal en etapa terminal | ESRD | Enfermedad Renal Crónica Etapa 5Estados Unidos
-
Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)TerminadoFallo renal agudo | Insuficiencia renal cronicaAustria
-
Angiodynamics, Inc.TerminadoEnfermedad Renal Crónica | Lesión renal aguda | Fallo renal agudo | Insuficiencia renal crónica inducida por contrasteEstados Unidos