Addressing the Need for Clinical Trial End Points in Autosomal Dominant Polycystic Kidney Disease: A Report From the Polycystic Kidney Disease Outcomes Consortium (PKDOC).

Smith, Kimberly A; Thompson, Aliza M; Baron, David A; Broadbent, Steven T; Lundstrom, Gary H; Perrone, Ronald D

Smith, Kimberly A; Thompson, Aliza M; Baron, David A; Broadbent, Steven T; Lundstrom, Gary H; Perrone, Ronald D.

Afiliación

Smith KA; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Thompson AM; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Baron DA; Polycystic Kidney Disease Foundation, Kansas City, MO.
Broadbent ST; Critical Path Institute, Tucson, AZ.
Lundstrom GH; Critical Path Institute, Tucson, AZ.
Perrone RD; Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA. Electronic address: rperrone@tuftsmedicalcenter.org.

Am J Kidney Dis ; 73(4): 533-541, 2019 04.

Article en En | MEDLINE | ID: mdl-30600104

Asunto(s)

Ensayos Clínicos como Asunto; Consenso; Nefrología/métodos; Riñón Poliquístico Autosómico Dominante/terapia; Sociedades Médicas; Progresión de la Enfermedad; Humanos

Palabras clave

PKD Outcomes Consortium (PKDOC); Polycystic kidney; autosomal dominant polycystic kidney disease (ADPKD); biomarker; clinical trials; drug approval; drug development; progression; surrogate endpoint; total kidney volume (TKV); trial design

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Texto completo: 1 Colección: 01-internacional Asunto principal: Sociedades Médicas / Ensayos Clínicos como Asunto / Riñón Poliquístico Autosómico Dominante / Consenso / Nefrología Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Am J Kidney Dis Año: 2019 Tipo del documento: Article País de afiliación: Moldova

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