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

Phase 3

Completed

• Conditions: Secondary Hyperparathyroidism; End Stage Renal Disease
• Interventions: Drug: cinacalcet

• Registration Number: NCT00117052
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-04
• Primary Completion: 2005-11
• Study Completion: 2006-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 673

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
During dialysis visit	cinacalcet	Cinacalcet is given during the dialysis visit
Post-dialysis meal	cinacalcet	Cinacalcet is administered with a post-dialysis meal

Primary Outcome Measures

Name	Time	Method
Number of subjects with PTH less than or equal to 300pg/mL	21 week dose optimisation phase

Secondary Outcome Measures

Name	Time	Method
Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes	Dose Optimisation phase 21 weeks
Safety of cinacalcet	21 weeks