Proteinuria

In this example, the subjects had AKI at the time of enrollment in the trial. Historical laboratory data on kidney function were collected at baseline. The sponsor collected historical data on urine albumin, protein, creatinine, and associated ratios to assess the current episode of AKI. Because the data were from historical records, the sponsor allowed flexibility in what was collected to avoid any calculations by the investigator, and to account for the various types of information available from the laboratories used. Note that LOINC codes were not included because they were not provided directly by the laboratory. These historical results could have been determined from a random urine sample (aka spot urine) or a timed urine collection.

For timed urine collections, some laboratories may report the urine volume and the amount of protein and creatinine in the sample, whereas other laboratories may report the concentration of protein in the sample (amount/volume of urine). In this example, the sponsor reported the UPCR and UACR at baseline in the study report. When the ratios were not provided by the laboratory, they were derived by the sponsor in the ADaM dataset (not shown).