Iron deficiency anemia is a common complication of CKD, and the prevalence and severity of IDA increases as kidney disease progresses. It is estimated that there are approximately 1.6 million people living in the U.S. with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anemia. If ferric citrate is approved for the treatment of iron deficiency anemia in stage 3 – 5 NDD CKD patients, it would be the only
The Phase 3 study compared treatment with ferric citrate to placebo in 234 patients who previously had not adequately responded to or tolerated current oral iron therapies. The study achieved the primary endpoint with 52 percent (61/117) of patients who received ferric citrate achieving a 1g/dL or greater rise in hemoglobin at any time point during the 16-week randomized efficacy period, compared to 19 percent (22/115) in the placebo group (p<0.001), a clinically meaningful and statistically significant improvement. Two patients in the placebo group discontinued the study and were not included in the efficacy analysis – one discontinued after randomization prior to receiving placebo, one discontinued after taking a dose of placebo but before having laboratory values drawn. Statistically significant differences in all pre-specified secondary efficacy endpoints were also observed. During the full 24 weeks of the study, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile, with diarrhea reported as the most common adverse event.
“These Phase 3 results demonstrate that ferric citrate can effectively raise hemoglobin levels in stage 3 – 5 non-dialysis dependent chronic kidney disease patients, with effects observed as early as two weeks post-treatment initiation,” said
About the Phase 3 Registration Study
The pivotal Phase 3 study enrolled 234 patients who previously had not adequately responded to or tolerated oral iron therapies at 32 clinical sites in
|Baseline laboratory values:||Ferric Citrate (FC)
|Serum phosphate (mg/dL)||4.2||4.1|
The study’s chairmen are
Efficacy and safety analyses were performed on an intent-to-treat population and included all enrolled patients who received at least one dose of ferric citrate or placebo and one post-treatment laboratory assessment. The analysis also used a sequential gatekeeping strategy for statistical testing of the secondary endpoints.
Top-line Efficacy Results:
|Primary endpoint:||Ferric Citrate (FC)
|Proportion of patients achieving an increase in hemoglobin of > 1.0 g/dL at any time point during efficacy period* (%)||52.1||19.1||<0.001|
|Mean change in hemoglobin (g/dL)||0.75||-0.08||<0.001|
|Mean change in TSAT (%)||17.8||-0.6||<0.001|
|Mean change in ferritin (ng/mL)||162.5||-7.7||<0.001|
|Proportion of patients with a durable response during the efficacy period (%)**||48.7||14.8||<0.001|
|Mean change in serum phosphate (mg/dL)||-0.43||-0.22||0.02|
* Efficacy period defined as the 16-week randomized, double-blind, placebo controlled period
** Sustained treatment effect on hemoglobin was defined as a mean change from baseline ?0.75 g/dL over any 4-week time period during the efficacy period, provided that an increase of at least 1.0 g/dL had occurred during that 4-week period.
Top-line Safety Results:
The safety analysis demonstrated that ferric citrate was generally well tolerated in adults with stage 3-5 NDD CKD. Specifically, the results showed:
The company plans to submit detailed Phase 3 results for presentation at a premier kidney disease medical meeting taking place in the fourth quarter of 2016.
About Non-Dialysis Dependent Chronic Kidney Disease and Iron Deficiency Anemia
It is estimated that approximately one in 10 U.S. adults are affected by chronic kidney disease (CKD), which has no cure. Treatment today consists of measures to help control signs and symptoms, reduce the impact of many complications to make a person more comfortable and slow disease progression.
Iron deficiency anemia is one of the most common complications of chronic kidney disease. IDA develops early in the course of CKD and worsens with disease progression, is extremely prevalent in the non-dialysis dependent CKD population and is associated with fatigue, lethargy, decreased quality of life and is also believed to be associated with cardiovascular complications, hospitalizations, and increased mortality. There are five stages of CKD; in stages 1 and 2 people are typically under the care of a primary care physician and have a mild loss of kidney function. Typically, as people progress to stage 3 hemoglobin levels begin to fall, the patient experiences moderate to severe loss of kidney function and is generally referred to a nephrologist. Stage 4 is characterized as advanced disease with multiple complications. Stage 5 is considered kidney failure and the stage in which a patient would initiate dialysis. It is estimated that approximately 1.6 million adults with stage 3-5 CKD in the U.S. alone are also afflicted with iron deficiency anemia. Currently available oral iron supplements are associated with limited efficacy and dose-limiting tolerability issues. No oral iron medicines are currently
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About Auryxia™ (ferric citrate)
Auryxia™ (ferric citrate) was approved by the
Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT), whereas these parameters remained relatively constant in patients treated with active control (Renvela® and/or Phoslo®). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.
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 IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: 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 as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.
For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/
Some of the statements included in this press release 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 risk that we may not be able to successfully market Auryxia in the U.S. for patients with chronic kidney disease on dialysis; the risk that the
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