20070360 Incident Dialysis

Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination With Low Dose Vitamin D for the Treatment of Subjects With Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

Inclusion Criteria:

• Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study
• Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L)
• Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
• Subject will be able to complete the study, to the best of his/her knowledge
• Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

• Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
• Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
• Anticipated parathyroidectomy (partial or full) within 6 months after randomization
• Have a scheduled date for kidney transplant surgery
• Received cinacalcet since initiating hemodialysis
• Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
• Subject is pregnant (eg, positive HCG test) or is breast-feeding
• Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
• Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
• Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
• Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
• Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).