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A majority of Stage 5 End-Stage Renal Disease patients on dialysis suffer from a serious complication known as Secondary Hyperparathyroidism (SHPT), a condition associated with increased levels of Parathyroid Hormone (PTH) and if left un-treated can lead to mineral bone disorders. PTH is important because it helps to control the amount of calcium and phosphorous in our bodies.

SHPT in dialysis patients is caused by the lack of active Vitamin D which results in low serum calcium concentrations. When this happens, PTH secretion increases to mobilize calcium from the bone. This high concentration of PTH helps to keep the serum calcium concentration normal. If SHPT is left untreated, there is a greater chance that the patientís bones will become weak and brittle, leading to fractures and bone pain. Continued SHPT may also lead to enlargement of the parathyroid glands and loss of the ability to regulate PTH concentrations. Since the kidneys are no longer functioning, the body does not have enough active vitamin D to maintain serum calcium concentrations in the normal range.

Calcitriol IV Injection is the active form of vitamin D. It is administered to dialysis patients by a registered nurse as an intravenous injection. Calcitriol prevents and treats SHPT by increasing the absorption of calcium from the diet to correct the serum calcium concentrations. As the serum calcium concentrations increase towards normal, the production of PTH decreases. Calcitriol also stimulates the deposition of calcium into bones to reverse the effects of PTH. By reducing the patientís PTH level, they have better control and balance of their parathyroid hormone, vitamin D, calcium and phosphorus levels in the blood.

Rockwell's FDA approved Calcitriol IV Injection is the lowest cost, lowest dose active form Vitamin D and is packaged in vials. It is more potent than branded Vitamin D drugs and is shown to be therapeutically equivalent in safety and efficacy to these agents. The 1 microgram (mcg) dose Calcitriol injection is cost effectively administered during each dialysis session. In dialysis patients, Calcitriol IV Injection is positioned to become the new standard of care in the treatment of SHPT.

Rockwell Medical Technologies, Inc.
30142 Wixom Road - Wixom, MI 48393 USA
phone 800 449-3353 - fax 248 960-9119