Overview

Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) to K/DOQI recommended targets in subjects with end stage renal disease (ESRD) receiving hemodialysis, on bio-intact parathyroid hormone, corrected serum calcium, serum phosphorus, and calcium phosphorus product.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Cinacalcet
Cinacalcet Hydrochloride
Criteria
Inclusion Criteria: - Men and women must agree to use highly effective contraceptive
measures throughout the study - Prescribed hemodialysis for at least 3 months before study
day 1 - Must be receiving IV vitamin D sterols during the 30 days before day

1 (greater than 2 µg of paricalcitol, greater than 1 µg of doxercalciferol, or greater than
0.5 µg of calcitriol per dialysis treatment) - The mean of 2 biPTH determinations obtained
from the central laboratory must be greater than or equal to 80 pg/mL and less than or
equal to 160 pg/mL - The mean 2 albumin corrected serum calcium determinations obtained
from the central laboratory must be greater than or equal to 8.4 mg/dL - The mean of two Ca
x P calculations, based on corrected serum calcium and serum phosphorus determinations
obtained from the central laboratory must be greater than 55 mg²/dL Exclusion Criteria: -
Have an unstable medical condition, defined as having been hospitalized, other than for
dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in
the judgment of the investigator - Pregnant or nursing females - Parathyroidectomy in the
12 weeks 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 antidepressant amitriptyline is permitted - Received, within 21 days
before day 1, therapy with medications that are potent inhibitors (e.g., ketoconazole,
itraconazole and erythromycin) or inducers (e.g., rifampin and St. John's Wort) of the
enzyme CYP3A4. Phenytoin, phenobarbital and carbamazepine are also potent inducers of this
enzyme. However, subjects on a stable dose of any of these anti-convulsants at baseline,
with no evidence of seizure activity in the past 2 months may be eligible for the study -
Experienced a myocardial infarction within 12 weeks prior to day 1 - Currently enrolled in,
or have not yet completed at least 30 days since ending other investigational device or
drug trials, or are receiving other investigational agents (experimental dialysis machines
are acceptable) - Current gastrointestinal disorder that may be associated with impaired
absorption of orally administered medications or an inability to swallow tablets -
Participated in other studies with cinacalcet HCl - Disorder that would interfere with the
understanding and giving of informed consent or compliance with protocol requirements