What is Chronic Kidney Disease (CKD)?

Chronic Kidney Disease or CKD is characterized by progressive loss of the ability to remove waste and maintain fluid and chemical balances in the body.

Stage	Description	GFR* mL/min/1.73 m²	Number of Patients
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

Secondary Hyperparathyroidism (SHPT)
SHPT is part of the complex, interrelated series of abnormalities and complications associated with CKD known as Mineral and Bone Disorder (CKD-MBD). CKD-MBD includes disturbances in mineral metabolism (serum iPTH, calcium, and phosphorus), renal osteodystrophy, and vascular or other soft-tissue calcification. ^[3]

As a CKD patient’s kidney function declines, the ability to convert 25D to 1,25D is lost. 1,25D plays a key role in modulating parathyroid function. Thus
vitamin D deficiency results in increased parathyroid hormone (PTH) synthesis. Elevated blood levels of PTH in CKD patients due to either a deficiency of 1,25D or hypocalcemia is characterized as SHPT. ^[1]

Progressive decline of vitamin D hormone and elevation of iPTH begin early in CKD^[4-8]

Elevated blood levels of PTH significantly and adversely effect the function of almost every organ. ^[1]

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 current 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 ≥ 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 ≥ 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 or call Genzyme Medical Information at 1-800-847-0069.