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