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The open-label, single-center study evaluated use of ferric citrate compared to standard of care treatment (SOC) in late-stage non-dialysis dependent CKD patients. Patients with eGFR < 20 ml/min who were not anticipated to start renal replacement therapy (dialysis) within 8 weeks of study initiation were randomized 2:1 to receive a fixed dose of ferric citrate (two tablets per meal) or SOC. The data presented today are based on the 199 evaluable patients (133 in the ferric citrate-treated arm, and 66 in the SOC arm) who were seen for at least one follow up visit. Of those randomized to the standard of care arm, 37 percent received phosphate binders during the pre-dialysis period. Patients enrolled in the study were seen monthly for 9 months, or, for those who started dialysis treatment, for three months post dialysis initiation. The data presented today are related to the non-dialysis period of the study (9 months for those who did not progress to dialysis or the time leading up to dialysis for patients who progressed).
“The data from this study suggest that administering ferric citrate to late-stage pre-dialysis patients not only improves biochemical parameters associated with chronic kidney disease, but also has the potential to delay the need for dialysis,” said
The study evaluated many biochemical parameters associated with CKD, including hemoglobin, transferrin saturation (TSAT), ferritin, phosphorus, and intact-FGF23 in study patients. At baseline, these parameters were consistent between the treatment groups. There were however more patients with diabetes randomly assigned to the standard of care arm. In the ferric citrate treatment group, 76 of the 133 patients completed the full nine months of the study, 30 initiated renal replacement therapy, 16 terminated early, 8 received a transplant and 3 died. In the SOC treatment group, 29 of the 66 patients completed nine months of the study, 31 initiated renal replacement therapy, 4 terminated early and 2 died. At nine months, patients receiving ferric citrate in the non-dialysis period had significant improvements compared to those in the SOC arm in all biochemical parameters measured in this study, as listed in the table below:
|Non-Dialysis Period||Hg (g/dL)
(FC n=133, SOC n=66)
(FC n = 76, SOC n = 29)
|p-value (Wilcoxon Rank-Sum test,
FC vs. SOC at 9 months)
Additionally, the study evaluated the number of patients in each arm that progressed to death, dialysis or transplant in each cohort over the 9 month period. After adjusting for baseline characteristics, patients in the ferric citrate treated arm were less likely to reach this endpoint (for all patients, Cox proportional hazards: HR 0.44, p=0.006, CI 0.25, 0.79; for diabetic patients, HR 0.41, p=0.02, CI 0.2, 0.85).
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About Auryxia (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g., hemochromatosis, should not take AURYXIA® (ferric citrate).
Iron Overload: Iron absorption from AURYXIA may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on AURYXIA. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental Ingestion: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep AURYXIA away from children. Call a poison control center or your physician in case of an accidental overdose in a child.
Adverse Events: The most common adverse events occurring in at least 5% of patients treated with AURYXIA were, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and high levels of potassium in the blood.
AURYXIA contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
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Some of the statements included in this press release, particularly those regarding the post-hoc analysis and the effectiveness of Auryxia, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the benefit seen by patients using Auryxia outside of the clinical setting; as well as our ability to successfully market Auryxia and whether we can increase adoption of Auryxia in patients with CKD on dialysis and successfully launch Auryxia for the treatment of iron deficiency anemia in patients with chronic kidney disease, not on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; our ability to continue to supply Auryxia to the market; the risk that increased utilization by
KERYX BIOPHARMACEUTICALS CONTACT
Source: Keryx Biopharmaceuticals, Inc.