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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117052
• Other study ID #: 20040143
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: May 21, 2013
• Start date: September 2004
• Est. completion date: February 2006

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 673
• Est. completion date: February 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• cinacalcet
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Schaefer RM, Bover J, Dellanna F, Sanz D, Asensio C, Sánchez González 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with PTH less than or equal to 300pg/mL		21 week dose optimisation phase	No
Secondary	Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes		Dose Optimisation phase 21 weeks	No
Secondary	Safety of cinacalcet		21 weeks	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling