Practicing physicians frequently obtain laboratory assessments of kidney function in their routine management of patients with diabetes. Two tests that are commonly performed are the estimated glomerular filtration rate (eGFR) and the urinary albumin to creatinine ratio (ACR). Results of these tests are often used to determine patient eligibility for clinical trials of drugs to treat patients with diabetic kidney disease (DKD).
One challenge that drug developers and clinical trialists face is in choosing eGFR and ACR criteria that support the aims of the clinical study—without hindering recruitment.
To address this issue, researchers at Covance and LabCorp queried a LabCorp database of 329,841 diabetic patients to analyze real-world data. They wanted to understand the distribution of eGFR and ACR values among diabetic patients in the United States and assess how these laboratory parameters predicted renal disease progression.
Pharmacokinetic (PK) data guide the safe and effective management of a drug treatment; however, with diabetic patients, PK studies can be especially challenging. Varying degrees of kidney disease in patients can affect the PK characteristics of the drug and the reliability of the study results.
From screening patients to determining doses, testing a drug for diabetic patients involves several important considerations.
The importance of early work
Even before a drug reaches the clinical stages, early work can help set the stage. Preclinical research is very important in identifying agents with activity in the diabetic spectrum, while studies in early toxicology provide valuable direction as to whether the risks are acceptable in the diabetic population.
Given that most diabetic drugs affect the kidneys, performing an early renal study on a model can determine if the drug has a future in the diabetic space and may help guide earlier go/no-go decisions ‒ before allocating additional resources to the efforts. Continue reading