Overview

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

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Cinacalcet
Cinacalcet Hydrochloride
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