KDOQI™ Goals

Treatment goals for the 4 key KDOQI™ secondary hyperparathyroidism laboratory parameters in dialysis patients

Laboratory target values¹

*Based on intact PTH assays.¹
^†Corrected total serum calcium levels.¹

Monitoring frequency of parathyroid hormone (PTH), serum calcium, and serum phosphorus in stage 5 chronic kidney disease (CKD)^1‡§

‡For more information, see KDOQI™ guidelines pages S12 and S52.
^§Measurements should be made more frequently if patient is receiving therapy for PTH, phosphorus, or calcium abnormalities.

KDOQI™ Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease (Stage 5). KDOQI™ is a trademark of the National Kidney Foundation, Inc.

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Important Safety Information

Sensipar® treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Sensipar® lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia.

Significant reductions in calcium may lower the threshold for seizures. Secondary hyperparathyroidism (HPT) patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.

In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL.

Patients with moderate to severe hepatic impairment should be monitored throughout treatment with Sensipar®, as cinacalcet exposure assessed by area under the curve (AUC) was higher than in patients with normal hepatic function.

Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.

The most commonly reported side effects were nausea, vomiting, and diarrhea.

References

National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(suppl 3):S1-S201.

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