SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism
1 other identifier
interventional
673
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedMay 23, 2013
May 1, 2013
1.2 years
June 30, 2005
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with PTH less than or equal to 300pg/mL
21 week dose optimisation phase
Secondary Outcomes (2)
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
Study Arms (2)
During dialysis visit
ACTIVE COMPARATORCinacalcet is given during the dialysis visit
Post-dialysis meal
ACTIVE COMPARATORCinacalcet is administered with a post-dialysis meal
Interventions
All eligible subjects were assigned to receive once daily oral doses of cinacalcet, but were randomised in a 1:1 ratio to receive the drug either with the first meal after dialysis or during the dialysis visit on dialysis days.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Schaefer RM, Bover J, Dellanna F, Sanz D, Asensio C, Sanchez Gonzalez MC, Gross P, Zani V, Carter D, Jehle PM. Efficacy of cinacalcet administered with the first meal after dialysis: the SENSOR Study. Clin Nephrol. 2008 Aug;70(2):126-34. doi: 10.5414/cnp70126.
PMID: 18793528RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 4, 2005
Study Start
September 1, 2004
Primary Completion
November 1, 2005
Study Completion
February 1, 2006
Last Updated
May 23, 2013
Record last verified: 2013-05