What is Chronic Kidney Disease (CKD)?

Chronic kidney disease or CKD causes progressive loss of kidney function. Complications resulting from decreased kidney function^[1]include an inability to filter waste products and maintain a balanced level of fluids, minerals and other substances within the body.

Stage	Description	GFR* mL/min/1.73 m²	Number of Patients¹
1	Slight kidney damage with normal or increased filtration	More than 90	5,900,000
2	Mild decrease in kidney function	60-89	5,300,000
3	Moderate decrease in kidney function	30-59	7,600,000
4	Severe decrease in kidney function	15-29	400,000
5	Kidney failure; requiring dialysis or transplantation	Less than 15	300,000

About Secondary Hyperparathyroidism in Chronic Kidney Disease
An important role in kidney function is mineral metabolism and balance. A key function of the kidney is to convert natural vitamin D (25(OH)D) into 1,25-dihydroxyvitamin D₃ (1,25 D). Vitamin D in the form of 25(OH)D must pass through the kidneys and liver to be converted into 1,25D. Conversion of 1,25D is needed for calcium absorption, bone remodeling and cell growth control.

In CKD, the impaired synthesis of 1,25D results in a decrease in absorption of calcium from the gastrointestinal tract. The parathyroid gland, which regulates blood levels of calcium, responds to this decrease by increasing production and secretion of parathyroid hormone (PTH), which signals the bones to release calcium. As CKD progresses, PTH production and secretion increases. Continued elevation of PTH is called secondary hyperparathyroidism (SHPT).

SHPT is associated with a range of complications including renal osteodystrophy, calcification, cardiovascular disease and immune dysfunction.

SHPT presents in early CKD and increases in prevalence and severity as CKD progresses ^[1,5]

	Stage 3	Stage 4	Stage 5
Patients with elevated PTH	30%	60%	85%

Treatment of Secondary Hyperparathyroidism
There are a variety of available treatments in the earlier stages of CKD including vitamin D, calcium supplementation and phosphate restriction.

Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease (capsules) and in patients with chronic kidney disease on dialysis (capsules and injection)∙ Hectorol is contraindicated in patients with a tendency towards hypercalcemia or evidence of vitamin D toxicity ∙ Overdosage of any form of vitamin D is dangerous∙ Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs∙ Chronic hypercalcemia can lead to generalized vascular and soft tissue calcification∙ Pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol treatment to avoid possible additive effects and hypercalcemia∙ Magnesium-containing antacids and Hectorol should not be administered concomitantly∙ Adverse effects of Hectorol treatment are: hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of iPTH∙ Adverse events reported by ³ 5% of the Hectorol-treated predialysis patients included: infection, chest pain, constipation, dyspepsia, anemia, dehydration, depression, hypertonia, insomnia, paresthesia, increased cough, dyspnea and rhinitis ∙ Adverse events reported by ³ 5% of the Hectorol-treated dialysis patients included: headache, malaise, bradycardia, nausea/vomiting, edema, dizziness, dyspnea, and pruritus. See Hectorol Capsules Full Prescribing Information or Hectorol Injection Full Prescribing Information.


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