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RG012-01

ATHENA: Natural History of Disease Study in Alport Syndrome Patients

Ensayo de Sanofi en Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2 (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

165

previstos

Centros

15

Fin del objetivo primario

dic 2017

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en sep 2014.

Qué mide

To characterize the natural decline of renal function markers (Glomerular Filtration Rate [GFR] and creatinine) in patients with Alport syndrome over the course of up to 120 weeks (del registro, en inglés) (hasta 120 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThere is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients. Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow an assessment of the rate of change of established clinical endpoints, such as GFR and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects whose renal function is steadily declining. The identification of surrogate markers that track the decline of renal function and could correlate with time to end-stage renal disease (ESRD) is a key goal of the natural history study.

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Ficha completa en ClinicalTrials.gov (NCT02136862), actualizada en jun 2019.