Leverage Our Renal / Hepatic Insufficiency

Complete Solution to Renal or Hepatic Insufficiency Studies

Celerion has extensive experience in conducting renal and hepatic impairment studies which enables us to provide you the best guidance and strategy for your trial. Our experienced site networks, investigators, project managers, and pharmacologists are brought in early to provide insight to the eligibility criteria and the study design issues that may impact your study.

Expert Sites Coupled with Experienced Project Managers

Leverage our Expansive US and EU Network of Sites

We have a network of preferred specialty sites that have over 100 years of combined experience in conducting renal and hepatic impairment PK studies. These go-to sites are all experienced clinics with large, established databases of patients with at all levels of renal and hepatic impairment. Additionally, these are sites qualified by Celerion with established systematic working processes.

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Celerion’s US and EU Site Network

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. In addition, our experienced team of project managers and CRAs seamlessly acts as an extension of your study team.

Discover how Celerion’s expertise ensures success in renal and hepatic insufficiency studies

Discover how Celerion’s expertise ensures success in renal and hepatic insufficiency studies. In this video, Abbey Townsend, Senior Director of Global Clinical Development, explains key challenges and strategies for managing PK studies efficiently and cost-effectively, highlighting our partnerships with top investigators.

Optimized Patient Recruitment for Renal and Hepatic Impairment PK Studies

Although these studies involve a relatively small number of renally or hepatically impaired patients plus 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.
Concomitant 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.
The majority of studies involve an “adaptive like” or “stage” designs. These involve enrolling one or two groups first and doing interim analysis on safety and PK before deciding if and at what dosage to do the next group.