Of the 422 million people in the world with type 1 and 2 diabetes, 20-30% will develop diabetic nephropathy, also called diabetic kidney disease (DKD) – the leading cause of renal failure in the western world1.
From the perspective of drug developers, testing new therapies to prevent, treat or reverse this serious complication relies on biomarkers for timely and accurate patient identification and efficacy or safety monitoring.
Jennifer Ennis, MD, medical director at LabCorp and D. Walt Chandler, PhD, executive director at LabCorp, recently shared their thoughts on today’s biomarkers to detect and monitor DKD.
As the diabetic epidemic grows, so does the prevalence of diabetic kidney disease (DKD), a frequent complication of both type 1 and 2 diabetes. Diabetic nephropathy is the leading cause of end-stage renal disease, and despite its global health burden and increased prevalence, no specific regulatory guidelines exist for developing drugs for diabetic renal disease.
Despite expert design and thoughtful planning, all studies will encounter risks and issues. How well these risks and issues are managed directly correlates to how well a study is run. But tracking issues and their mitigating actions can be a cumbersome and inefficient process.
To gather insights about how to solve this ongoing problem, we met with study teams, representatives from multiple functional areas, oversight teams and clients. See how these critical insights were used to design a flexible system centered on operational and quality excellence. Continue reading
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.
Current guidance on rheumatoid arthritis (RA) stresses the importance of considering comorbidity when assessing disease activity and making clinical decisions.1 Comorbidities commonly associated with RA include cardiovascular disease (CVD), lung disease and malignancy.2
The complex relationship between RA and CVD comorbidities
The presence of CVD itself has been shown to increase the risk of death in RA patients by approximately 50%,3 and there is an emerging relationship between RA, CVD and the therapies used to treat them. Continue reading
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