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document
Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD . BACKGROUND The safety and efficacy of paricalcitol injection have been well established for the prevention and treatment of secondary hyperparathyroidism ( SHPT ) in patients with chronic kidney disease ( CKD ) stage 5 . The capsule form of paricalcitol was developed to provide a convenient dosage form for patients with stages 3 and 4 CKD . METHODS Three randomized , placebo-controlled , phase-3 trials were conducted in patients with stages 3 and 4 CKD with SHPT . Enrollment criteria included an estimated glomerular filtration rate between 15 and 60 mL/min/1.73 m2 ( 0.25 and 1.00 mL/s/1.73 m2 ) , an average of 2 consecutive intact parathyroid hormone ( iPTH ) levels greater than 150 pg/mL ( ng/L ) , 2 consecutive serum calcium levels between 8.0 and 10.0 mg/dL ( 2.00 and 2.50 mmol/L ) , and 2 consecutive serum phosphorus levels of 5.2 mg/dL or less ( < or = 1.68 mmol/L ) . Two studies used a thrice-weekly dosing regimen and 1 study used a once-daily dosing regimen for 24 weeks . Dosing was based on serum iPTH , calcium , and phosphorus levels . The primary efficacy end point is 2 consecutive decreases in iPTH levels greater than 30 % from baseline . RESULTS Two hundred twenty patients participated ( n = 107 , paricalcitol ; n = 113 , placebo ) . At least 2 consecutive decreases in iPTH levels of 30 % or greater from baseline occurred in 91 % of paricalcitol versus 13 % of placebo patients ( P < 0.001 ) . Incidences of hypercalcemia , hyperphosphatemia , and elevated calcium-phosphorus product levels were not significantly different between groups . Similarly , no significant differences in urinary calcium and phosphorus excretion or deterioration in kidney function were detected in patients administered paricalcitol compared with placebo . CONCLUSION Paricalcitol capsule was well tolerated and effectively decreased iPTH levels with minimal or no impact on calcium levels , phosphorus balance , and kidney function in patients with stages 3 and 4 CKD .
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Intervention_Pharmacological
Paricalcitol capsule
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Intervention_Pharmacological
paricalcitol
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
paricalcitol
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Intervention_Control
placebo
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Intervention_Pharmacological
Paricalcitol
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Outcome_Physical
secondary hyperparathyroidism
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Outcome_Other
safety
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Outcome_Other
efficacy
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Outcome_Physical
secondary hyperparathyroidism ( SHPT )
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Outcome_Physical
serum calcium levels
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Outcome_Physical
serum phosphorus levels
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Outcome_Other
2 consecutive decreases in iPTH levels
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Outcome_Other
decreases in iPTH levels
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Outcome_Physical
hypercalcemia
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Outcome_Physical
hyperphosphatemia
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Outcome_Physical
elevated calcium-phosphorus product levels
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Outcome_Physical
urinary calcium and phosphorus excretion
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Outcome_Physical
deterioration in kidney function
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Participant_Condition
secondary hyperparathyroidism in stages 3 and 4 CKD
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Participant_Condition
secondary hyperparathyroidism
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Participant_Condition
SHPT
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Participant_Condition
patients with chronic kidney disease ( CKD ) stage 5
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Participant_Condition
patients with stages 3 and 4 CKD with SHPT
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Participant_Sample-size
Two hundred twenty patients
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Participant_Sample-size
107
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Participant_Sample-size
113