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

Condition(s) targeted: Secondary Hyperparathyroidism; End Stage Renal Disease

Intervention: cinacalcet (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Official title: SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism

Study design: Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: Number of subjects with PTH less than or equal to 300pg/mL

Secondary outcome:

Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes

Safety of cinacalcet

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrollment

- An iPTH determination within 14 days before randomization 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

randomization 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 hospitalized, 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

AmgenTrials clinical trials website

Starting date: September 2004
Ending date: February 2006
Last updated: June 13, 2008