The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
552
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
Number of Participants With Mean PTH ≤ 300 pg/mL
Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase
Time frame: Efficacy Assessment Phase (weeks 17 to 23)
Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL
Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase
Time frame: Efficacy Assesment Phase (weeks 17-23)
Number of Participants With Mean Ca x P < 55 mg^2/dL^2
Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 during the efficacy assessment phase
Time frame: Efficacy Assessment Phase (weeks 17 to 23)
Number of Participants With Mean Serum Ca < 9.5 mg/dL
Number of participants with mean serum calcium (Ca) \< 9.5 mg/dL during the efficacy assessment phase
Time frame: Efficacy Assessment Phase (weeks 17-23)
Number of Participants With Mean Serum P < 5.5 mg/dL
Number of participants with mean serum phosphorus (P) \< 5.5 mg/dL during the efficacy assessment phase
Time frame: Efficacy Assessment Phase (weeks 17 to 23)
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