Bone and Mineral Metabolism Disorders News

The European Commission has approved Fexeric (ferric citrate coordination complex) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease including both dialysis and pre-dialysis patients. The European Commission considered ferric citrate coordination complex a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe.

The Dialysis Outcomes and Practice Patterns Study (DOPPS) practice monitor (DPM) is showing several apparent practice changes related specifically to mineral and bone disorder management in dialysis patients.

Amgen has submitted a new drug application with the U.S. Food and Drug Administration for etelcalcetide (formerly AMG 416) to treat secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously at the end of the dialysis session.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending approval of Keryx Biopharmaceuticals Inc.'s ferric citrate to treat hyperphosphatemia in adults with chronic kidney disease not dependent on dialysis.

Editor's note: This article is the opening editorial by Dr. Wish for a special supplement published by Nephrology News & Issues in the February 2014 issue entitled, "Iron therapy and a quarter century of ESAs: What have we learned?"

Bone loss may be a sign of poor heart health in patients on dialysis, according to a study conducted by researchers at the University of Kentucky. The study, "High Parathyroid Hormone Level and Osteoporosis Predict Progression of Coronary Artery Calcification in Patients on Dialysis," appears in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

The drug cinacalet, which is sold under the trade name Sensipar by Amgen Inc., may help prevent bone fractures in dialysis patients, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology.

Almost all people with pre-dialysis kidney disease should receive statins according to current guidelines, reports a study appearing in an upcoming issue of the Journal of the American Society of Nephrology.

Researchers from the Dialysis Outcomes and Practice Patterns Study (DOPPS) released a fresh batch of data­­––through April of this year––from its Practice Monitor yesterday, showing that while adequacy and hemoglobins have stabilized, ferritin levels may be a cause for concern.

Amgen announced that more than 75% of hemodialysis patients who received the experimental drug AMG 416 (formerly known as velcalcetide) as part of a phase 3 study experienced a drop in their parathyroid hormone levels of more than 30%, compared with 9.6% for patients who received a placebo. The drug is being tested to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease, receiving hemodialysis.