The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

Inclusion Criteria:

• Age ≥ 18 years at screening
• Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening
• Informed consent provided by the study candidate
• For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and < 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory

Exclusion Criteria:

• Parathyroidectomy in the 12 weeks before the date of informed consent
• History of seizure within 12 weeks prior to randomization
• Scheduled for kidney transplant
• Parathyroidectomy anticipated within the next 6 months
• Liver function tests > than 2 x the Upper Limit of Normal
• Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial
• Subject has previously enrolled in this study
• General
• Other investigational procedures are excluded
• Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
• Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment
• Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment
• Subject has known sensitivity or intolerance to any of the protocol required therapies
• Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge
• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

56 weeks

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.