In almost all our trials, we check for drug effects on renal function by regular measurements of serum urea and creatinine, and for potential renal injury by regular urinalysis. We use serum cystatin-C as another marker of renal function, as it can be more reliable than creatinine.
When it’s crucial to test renal performance accurately and reliably, we offer measurement of glomerular filtration rate using IV 51Cr‑EDTA.
When there’s a particular need to test for renal injury, the HMR laboratory does on-site assay of
- urinary transferrin
- N-acetyl glucosaminidase (NAG)
Any or all of those methods can easily be incorporated in first-in-human trials.