A Research Study for Patients With End-Stage Renal Disease (ESRD)

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	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.
Cinacalcet	cinacalcet	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. Dose escalation of cinacalcet may occur based on iPTH values.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Mean PTH ≤ 300 pg/mL	Efficacy Assessment Phase (weeks 17 to 23)	Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL	Efficacy Assesment Phase (weeks 17-23)	Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase
Number of Participants With Mean Ca x P < 55 mg^2/dL^2	Efficacy Assessment Phase (weeks 17 to 23)	Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 during the efficacy assessment phase
Number of Participants With Mean Serum Ca < 9.5 mg/dL	Efficacy Assessment Phase (weeks 17-23)	Number of participants with mean serum calcium (Ca) \< 9.5 mg/dL during the efficacy assessment phase
Number of Participants With Mean Serum P < 5.5 mg/dL	Efficacy Assessment Phase (weeks 17 to 23)	Number of participants with mean serum phosphorus (P) \< 5.5 mg/dL during the efficacy assessment phase