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Wired News – Keryx Biopharmaceuticals Shares Results of Clinical Trial for Treating Patients with Advanced Chronic Kidney Disease with Ferric Citrate

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LONDON, UK / ACCESSWIRE / May 30, 2018 / If you want access to our free research report on Keryx Biopharma, Inc. (NASDAQ: KERX) ("Keryx"), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=KERX as the Company's latest news hit the wire. On May 25, 2018, the Company shared the data from an investigator sponsored clinical trial that showed the impact of the use of ferric citrate in treating patients with advanced chronic kidney disease (CKD). The Company presented the results at the recently-held 55th ERA-EDTA Congress held at Copenhagen, Denmark, from May 24, 2018, to May 27, 2018. Register today and get access to over 1,000 Free Research Reports by joining our site below:


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Details of the Clinical Study

The clinical trial was an open-label, single-center study that evaluated the use of ferric citrate in treating late-stage non-dialysis dependent CKD patients compared to the standard of care treatment (SOC). The clinical trial was conducted on patients who had an eGFR < 20 ml/min and who were not expected to start renal replacement therapy (dialysis) within 8 weeks of the start of the study. The patients were randomly segregated into two groups in the ratio of 2:1. One group received a fixed dose of ferric citrate (two tablets per meal), and the second group received SOC. A total of 199 patients were chosen for the study, of which 133 were treated with ferric citrate while the balance 66 patients were treated with SOC. Nearly 37% of the patients treated with SOC received phosphate binders during the pre-dialysis period. The patients who were a part of this trial were observed monthly for a nine-month period, whereas those patients who had started the dialysis treatment were observed three months after the start of dialysis. The data presented by the Company refers to the statistics from the non-dialysis period of the trial. This includes those patients who were observed for nine months and did not progress to dialysis or the time leading up to dialysis for patients who progressed.

Results of the Clinical Study

While analyzing the data from the clinical trial, the Company used many biochemical parameters associated with CKD, viz., hemoglobin, transferrin saturation (TSAT), ferritin, phosphorus, and intact-FGF23 in all the enrolled patients. At baseline, these parameters were consistent between the treatment groups. However, there were more diabetic patients who were randomly assigned to receive the SOC treatment.

Out of the 133 patients who were chosen to receive ferric citrate treatment, 76 patients completed the full nine months of the study; 30 patients started renal replacement therapy; 16 patients terminated early; 8 patients received a transplant; and 3 patients died.

In the 66 patients' group that received SOC treatment, 29 patients completed the nine months of the study; 31 patients started renal replacement therapy; 4 patients terminated early; and 2 patients died.

At the end of the nine months of the clinical trial, patients who had received the ferric citrate during the non-dialysis period showed significant improvements across all biochemical parameters of the trial compared to those patients who were treated with SOC. Overall, when comparing the patients progress towards death, dialysis, or transplant in each treatment scenario, it was noticed that patients who were treated with ferric citrate were less likely to reach dialysis or death.

Commenting on the results of the clinical study, Geoffrey Block, M.D, Director of Clinical Research at Denver Nephrology, said:

"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. With the impact of ferric citrate across multiple aspects of CKD, it is worth further investigation to determine which of these many factors is contributing to the reduced risk of renal replacement therapy observed in this study."

About Auryxia (ferric citrate) Tablets

Keryx's Auryxia (ferric citrate) tablets received approval from the US Food and Drug Administration (FDA) in September 2014 for the control of serum phosphorus levels in adult patients with CKD on dialysis, followed by the FDA's approval in November 2017 for Auryxia for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. These tablets contain 210 mg of ferric iron, equivalent to 1 gram of ferric citrate, and offers convenient mealtime dosing. The starting dose of Auryxia for the treatment of hyperphosphatemia for patients on dialysis is six tablets per day (two per meal), whereas for the treatment of iron deficiency anemia in patients not on dialysis, it is three tablets per day (one per meal).

About Keryx Biopharmaceuticals, Inc.

Boston, Massachusetts-based Keryx is focused on bringing innovative medicines to people with kidney disease. The Company has been operating for over 20 years and has 200 employees, consisting mostly of kidney care experts, including nephrologists, renal dietitians, nurses, and industry veterans in nephrology to jointly raise awareness of the kidney disease epidemic, give voice to this underserved population, and help healthcare professionals to improve the care of their patients.

Stock Performance Snapshot

May 29, 2018 - At Tuesday's closing bell, Keryx Biopharma's stock climbed 1.14%, ending the trading session at $5.31.

Volume traded for the day: 1.14 million shares.

Stock performance in the last month – up 11.09%; previous three-month period – up 11.32%; past six-month period – up 9.94%; and year-to-date - up 14.19%

After yesterday's close, Keryx Biopharma's market cap was at $636.37 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.


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