Overview

SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism

Status:
Completed

Trial end date:
2006-02-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Amgen

Treatments:

Cinacalcet
Cinacalcet Hydrochloride

Criteria

Inclusion Criteria: - CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month
before enrolment - An iPTH determination within 14 days before randomisation must be
greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum
calcium determination (corrected for calcium) within 14 days before randomisation 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 - Are currently breast-feeding - Are performing peritoneal dialysis - Have had
a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that
may be associated with impaired absorption of orally administered medications or an
inability to swallow tablets