A Research Study for Patients With End-Stage Renal Disease (ESRD)
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: cinacalcet; Standard of care
Intervention description: 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.
Intervention MeSH terms: Cinacalcet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 552.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Secondary HyperParaThyroidism (SHPT); Dialysis, End Stage Renal Disease (ESRD); KDOQI, Cinacalcet; Clinical Trial, Amgen

Summary:

      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.
    

Eligibility criteria:

        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