We believe the CKD patient community has unmet needs and we are committed to bringing new medicines to patients with renal disease.
In March, Keryx announced that its 24-week pivotal Phase 3 trial evaluating ferric citrate for the treatment of iron deficiency anemia in 234 adults with stage 3-5 non-dialysis dependent CKD demonstrated statistically significant differences between ferric citrate- and placebo-treated patients for the primary and all pre-specified secondary endpoints. In terms of safety, during the randomized efficacy period, the majority of adverse events reported were mild to moderate, with the most common being diarrhea. Read the full press release of the top-line Phase 3 results here, and presentation of final results at the American Society of Nephrology’s 2016 Kidney Week. The results were also published online in the Journal of the American Society of Nephrology (JASN) in January 2017.
Based on the Phase 3 results, Keryx submitted a supplemental new drug application (sNDA) for approval to the U.S. FDA in January 2017.
For additional information about this trial, please visit www.clinicaltrials.gov.
Phase 2 clinical data evaluating ferric citrate as a phosphate binder and as an oral iron treatment for IDA in pre-dialysis chronic kidney disease provided proof of concept for ferric citrate in IDA. The Phase 2 data successfully met its primary and key secondary endpoints with statistical significance. The Phase 2 data were published in the American Journal of Kidney Disease in 2015.