Table 4.
Impact of biomarkers on future acute kidney injury trials
| Problems with current trial design | Role of biomarkers |
|---|---|
| 1. Misclassification: inaccurate definition of “true AKI” or ATN | Diagnostic biomarkers: Use of urine biomarkers can lead to more accurate diagnosis of AKI and recruitment of a more homogenous patient population |
| 2. Enrollment of large proportion of low-risk patients who do not reach progression end points | Prognostic biomarkers:a Identification of high-risk patients likely to reach trial end points |
| 3. All patients enrolled in trials are given similar therapy | Predictive biomarkers:a Patients most likely to respond to a particular therapy are identified |
| 4. Current outcomes of efficacy and progression take months or years to develop; potentially beneficial therapies are terminated before reaching end points or harmful therapies are continued without recognition of harm | Pharmacodynamic biomarkers: Trials can be continued to harder end points or terminated early based on their effect on biomarkers. Such biomarkers may serve to monitor safety or efficacy. |
AKI, acute kidney injury; ATN, acute tubular necrosis.
a
Enrichment strategy: Prognostic and predictive biomarkers used as enrollment criteria can be used as “enrichment strategy.”