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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KDOQI^™ is a trademark of the National Kidney Foundation, Inc.

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Important Safety Information

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.

Sensipar® lowers serum calcium; therefore, it is important that patients have a serum calcium ≥ 8.4 mg/dL when initiating therapy.

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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