Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Traditional Vitamin D Therapy	Traditional Vitamin D Therapy	-
Cinacalcet	Cinacalcet	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)	Baseline to week 40-52	Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52

Secondary Outcome Measures

Name	Time	Method
Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)	Baseline to week 40-52	Number of participants achieving a \>=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)	week 40-52	Number of participants achieving Plasma PTH \< 300 pg/mL During Efficacy Assessment Phase (EAP)