Food and Drug Administration (FDA) Activities

Scientific Research

This section describes basic and clinical research activities supported or sponsored by the Federal government.

Food and Drug Administration (FDA)

1) Optimizing Renal Dose Adjustments in Patients with Chronic Kidney Disease: The FDA Center for Drug Evaluation and Research (CDER) is conducting research to assess the impact of different renal function estimating equations on drug-dosing, and to address the question of whether or not Cockcroft-Gault (CG)-based dosing adjustments in current labels should be retained or replaced. Dose adjustments for renally-cleared drugs are frequently based on CG estimates of renal function in drug labels. However, many clinical laboratories are now reporting estimates of renal function using the Modification of Diet in Renal Disease (MDRD) equation. Moreover, the standardization of the serum creatinine assay has raised concern about the continued use of CG for drug dosing, as the equation was developed using non-standardized creatinine measurements. This project compares the ability of the CG and newer equations to predict drug exposure and drug-related safety and efficacy outcomes with additional focus on drugs that are predominately eliminated by the kidney and have narrow therapeutic index.

This research project is funded by Critical Path Initiative research grant.

Contact Information
Nancy Xu, MD
Medical Officer, Center for Drug Evaluation and Research
Phone: 301-796-4079
Email: nancy.xu@fda.hhs.gov
Web: http://www.fda.gov/cder

2) Development of Patient Reported Outcomes in CKD:
Qualified patient reported outcomes that represent well-defined, reliable instruments can be used to establish the efficacy of a therapy. A recent joint workshop between the National Kidney Foundation (NKF) and FDA focused on the development of patient reported outcome measures for polycystic kidney disease, anemia of chronic kidney disease, and the nephrotic syndrome. Participants came from industry, academia, the Critical Path Institute, the NKF, the NIH and FDA. Discussions and work in this area are ongoing.

Contact Information
Melanie Blank
Medical Officer, Center for Drug Evaluation and Research
Phone: 301-796-1330
Email: Melanie.blank@fda.hhs.gov
Web: http://www.fda.gov/cder

Shona Pendse, M.D., M.M.Sc
Medical Officer, Center for Drug Evaluation and Research
Phone: 301-796-1109
Email: shona.pendse@fda.hhs.gov

3) Standardization of Data Elements for Clinical Trials in Polycystic Kidney Disease:
The FDA has joined efforts with the Polycystic Kidney Disease (PKD) Foundation and the Clinical Data Interchange Standards Consortium (C-DISC) to standardize data elements for clinical trials in PKD. One goal of the PKD Outcomes Consortium Project is to aggregate data from registries and clinical trials in PKD. Another objective is to explore kidney size and rate of size increase as potential surrogate endpoints for drug approval by determining their relationship with other important clinical manifestations of PKD (e.g., hypertension, pain, renal function and quality of life measures). PKD specific data elements are placed on the CDISC website for public review on a rolling basis.

Contact Information
Shona Pendse, M.D., M.M.Sc
Medical Officer, Center for Drug Evaluation and Research
Phone: 301-796-1109
Email: shona.pendse@fda.hhs.gov

4) FDA pre- and post-marketing regulation of medical products intended for diagnosis and monitoring of renal disease.

The FDA Center for Devices and Radiologic Health (CDRH) carries out the pre-market and post-market regulation of medical devices for the diagnosis and monitoring of renal disease. These devices include diagnostic devices (e.g. radiologic and other imaging devices; in vitro diagnostic tests; and sensing devices including telemonitoring devices); therapeutic devices (e.g. dialysis, surgical, and nutritional devices); and general hospital devices (e.g. sterilization equipment and bandages).

CDRH also oversees the regulation of combination products such as in vitro diagnostic tests that are intended to select or exclude patients for treatment with a particular drug; therapeutic medical devices that contain a drug that is passively and actively released by the medical device; and imaging materials such as radiocontrast media where the material is regulated as a drug to be used with an imaging medical device.

Contact Information
Max Robinowitz, MD
Medical Officer, Center for Devices and Radiological Health
Phone: 240-276-1300
Email: max.robinowitz@fda.hhs.gov
Web: http://www.fda.gov/MedicalDevices/default.htm