A Research Study for Patients With End-Stage Renal Disease (ESRD)
A Research Study for Patients With End-Stage Renal Disease (ESRD)
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.
Inclusion Criteria:

 -  ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration,
 haemofiltration, or peritoneal dialysis) for at least 1 month

 -  The mean of 2 iPTH determinations within 21 days before randomization and drawn at
 least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less
 than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater
 than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)

 -  The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same
 day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)

 Exclusion Criteria:

 -  Have an unstable medical condition, defined as having been hospitalised, other than
 for dialysis vascular access revision, within 30 days before day 1, or otherwise
 unstable in the judgment of the investigator

 -  Have had a parathyroidectomy in the 6 months before day 1

 -  Have received vitamin D therapy for less than 21 days before day 1 or required a
 change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects
 are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for
 the 21 days before day 1.

 -  Received, within 21 days before day 1 of the dose titration phase, therapy with
 medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow
 therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic
 antidepressants). The tricyclic antidepressant amitriptyline is permitted. -
 Experienced a myocardial infarction within 3 months prior to day 1

 -  Are currently enrolled in, or have not yet completed at least 30 days before day 1,
 other invasive investigational device or investigational drug trials, or are receiving
 other investigational agents (experimental dialysis machines are acceptable)

 -  Have a gastrointestinal disorder that may be associated with impaired absorption or
 orally administered medications or an inability to swallow tablets