Adaptive Bayesian Analysis of Serum Creatinine as a Marker for Drug-Induced Renal Impairment in an Early-Phase Clinical Trial | Zendy

PierreEdouard Sottas | Zendy; Gordon F. Kapke | Zendy; Jean-Marc Leroux | Zendy

Open Access

Adaptive Bayesian Analysis of Serum Creatinine as a Marker for Drug-Induced Renal Impairment in an Early-Phase Clinical Trial

Author(s) -

PierreEdouard Sottas,

Gordon F. Kapke,

Jean-Marc Leroux

Publication year - 2012

Publication title -

clinical chemistry

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.705

H-Index - 218

eISSN - 1530-8561

pISSN - 0009-9147

DOI - 10.1373/clinchem.2012.193698

Subject(s) - creatinine , renal function , dosing , placebo , medicine , drug , crossover study , confidence interval , clinical trial , pharmacology , pathology , alternative medicine

A concern with using creatinine for the identification of drug-induced renal impairment is that small changes in serum creatinine (SCr) that frequently are perceived as measurement bias or imprecision translate into important changes in the glomerular filtration rate. Important drug-generated changes in creatinine are difficult to detect because they are frequently observed within the reference interval. The design of a crossover drug protocol is an opportunity to use study participants as their own control to identify these small but important changes.

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