Celerion has conducted more than 20 of each type of study over the past 2-3 years. We have a network of preferred sites that has over 100 years of combined experience. Understanding the unique nature of this patient population and the study designs employed allows us to effectively complete your studies on-time and with excellent quality data.
The need for either organ to metabolize the drug impacts the potential safety and efficacy of the study drug; particularly in an impaired population. Celerion is knowledgeable about the importance of pharmacologic risks. Timely completion of these studies is often on the critical path for the completion of your dossier.
Experienced That Matters
Celerion’s familiarity in conducting renal and hepatic impairment studies enables us to provide you the best guidance and strategy, taking into account the many important considerations of your study. Our experienced investigators, project managers, and pharmacologists are brought in early to provide insight to the eligibility criteria and the study design issues that would impact your study. This enables us to work with you to design a program to meet your objectives. We provide you with options and the data needed to make fast, accurate decisions. We work with specialty sites that are experts in renal knowledge and provide reliable performance. These go-to sites are all experienced sites with large, established databases of patients with at all levels of renal impairment. Additionally, these are sites with which Celerion has worked extensively and established systematic working processes.
Our average study start-up times have continued to drop and now are approximately four weeks from the site contract to Institutional Review Board (IRB) approval. By the Investigator Meeting, our sites have usually identified and pre-screened subjects to start enrollment days after the meeting. On average, these studies have a sample size of 16-24 subjects and are completed in 16 weeks First Patient In - Last Patient Last Visit (FPI-LPLV) as a result of our performance, Celerion enjoys nearly 100% repeat customers.
Although these studies involve a relatively small number of renally impaired patients plus some healthy control subjects, they can still be difficult studies to execute if not planned properly
The following are some points to consider that will affect the project timelines of the study:
A thoughtful selection of inclusion and exclusion criteria for these special population trials is critical. Most renally or hepatically impaired subjects suffer from other diseases, which include diabetes, hypertension and metabolic disorders. Therefore, using narrow eligibility criteria needs to be balanced with maintaining the scientific integrity of the study.
Concomittant medications to treat these comorbidities, many of these medications cannot be discontinued, will require careful consideration for potential drug-drug interactions. Drug exclusions must also be balanced with recruitment challenges with patient safety always taking precedent.
Severely impaired patients are the most challenging group to recruit. These patients medical condition is fragile and often they are not healthy enough on the planned day of study to withstand the rigors of participating in a clinical trial, even for one or two days. The sites need to be flexible with their scheduling.
Severe renally impaired patients (eGFR < 30 mLs/min, no dialysis) do not stay long in this state (perhaps a few months) as there is pressure to move them into hemodialysis treatments. Therefore, the numbers of these patients available to the sites at any one time is low.
Over half of the renal studies that Celerion personnel have managed involved “adaptive like” or “stage” study designs. These involve enrolling one or two groups first and doing interim analysis on safety and Pharmacokinetic (PK) before deciding if and at what dosage to do the next group.
Impact of the FDA’s Revised Draft Guidance on Renal Impairment PK Studies—Trends, Challenges and Solutions