Keryx supports investigator-sponsored research conducted by independent researchers with Auryxia® (ferric citrate) tablets or within disease areas of interest to us. This research can provide valuable information regarding the safety, efficacy, pharmacology, and tolerability of Auryxia and supplement the comprehensive data generated in our registration trials. The research must be intended to contribute knowledge to the medical community. The budget must be reasonable and appropriate for the proposed work. We cannot guarantee that your proposal will receive support.
Types of Research Eligible for Support:
- Pre-clinical & clinical studies on the mechanism of action of ferric citrate
- Pre-clinical & clinical studies evaluating longitudinal effects of ferric citrate on clinical markers of anemia and/or mineral bone disorder
- Real world clinical and health economic outcomes studies with ferric citrate
To submit an Investigator Sponsored Research (ISR) proposal:
- Download and complete the Investigator Sponsored Research Concept Form
- Email the completed concept form along with any supporting documentation as PDFs either to your local medical science liaison (MSL) or to email@example.com.
Concept proposals are reviewed on a monthly basis and Keryx will strive to provide a decision via email within 6-8 weeks of initial submission. The ISR review committee evaluates all proposals based on numerous criteria including scientific merit, alignment with Keryx corporate policies and objectives, and compliance with any applicable U.S. Food and Drug Administration or federal healthcare program requirements.
The submission process for Investigator Sponsored Research is a two-step process involving a preliminary concept proposal submission and review. If approved, a more detailed protocol and budget submission will be required.
If you have questions, please contact your local medical science liaison (MSL) or the ISR administrator at firstname.lastname@example.org.