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Sevelamer hydrochloride

Dialysis Clinical Outcomes Revisited (DCOR) Trial

Ensayo de Sanofi en Enfermedad renal cronica.

Más ensayos de: Enfermedad renal crónica.

Fase

Fase 4

Estado

Completado

Participantes

2.000

previstos

Centros

73

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2001.

Qué mide

Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder. Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00324571), actualizada en mar 2015.