Clinical Trial Design
Data Harmonization in Kidney Transplantation
In coordination with the Clinical Data Interchange Standards Consortium (CDISC), Coalition for Accelerating Standards and Therapies (CFAST), FDA, and TransCelerate BioPharma, Inc., KHI assembled a workgroup to partner with these groups and helped define appropriate standards in the therapeutic area of kidney transplant. Learn more about this project here.CDISC Therapeutic Area User Guide for Kidney Transplantation
Data Standards in Diabetic Kidney Disease
In coordination with the Clinical Data Interchange Standards Consortium (CDISC), Coalition for Accelerating Standards and Therapies (CFAST), FDA, and TransCelerate BioPharma, Inc., KHI assembled a workgroup that helped define appropriate standards in the therapeutic area of diabetic kidney disease. KHI's specific role was providing clinical and medical expertise. Learn more about this project here.CDISC Therapeutic Area User Guide for Diabetic Kidney Disease
Pragmatic Trials in Dialysis: Challenges and Opportunities
Few randomized clinical trials have been conducted in this setting due to various perceived barriers – including FDA regulations related to data collection, lack of clarity around best practices for ensuring human subject protections, and cumbersome CMS requirements related to billing for patients involved in research. Learn more about this project here.Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative
Pharmacokinetics in Patients Receiving Continuous Renal Replacement Therapy
Patients in the intensive care unit often develop acute kidney injury (AKI) and require continuous renal replacement therapy (CRRT), a procedure that differs significantly from outpatient dialysis. While the rate of acute kidney injury in the United States has doubled during the last 10 years, less than 20% of the drugs used have been studied with regard to appropriate dosing for patients in intensive care units (ICUs) receiving CRRT. As a result, clinicians and pharmacists often end up making best guesses in terms of dosages of life saving drugs in critically ill patients.
The growing number of cases of AKI, increasing use of CRRT, and reliance on a large number of potentially life-saving medications in these critically ill patients necessitate a better understanding of basic pharmacokinetics in this setting. Standardized pharmacokinetics guided drug dosing studies during the pre-approval development process are urgently needed for drugs likely to be used in critically ill patients, and similar studies should be conducted on currently approved drugs commonly used in these patients.
A workgroup that included FDA staff, evaluated medication dosing during CRRT and prioritized drugs or classes of drugs to help generate key data to improve treatment for these critically ill patients.Pharmacokinetic Assessment in Patients Receiving Continuous RRT: Perspectives from the Kidney Health Initiative
Regulatory Policies and Positions Affecting Device Approval in the US
For medical device development, it is essential that device manufacturers and other stakeholders have optimal information regarding the standards and requirements for approval of clinical trial protocols and market approval for devices at the U.S. Food and Drug Administration. A workgroup was assembled that defined and studied a few broad categories of devices that have been marketed outside of the United States. The workgroup is determining the value of these devices in patient care, ascertaining pathways to expedite approvals in the United States (if appropriate), and then summarizing their findings in a white paper. Learn more about this project here.Hemodiafiltration to Address Unmet Medical Needs ESKD Patients Regulatory Considerations for Hemodiafiltration in the United States