SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism - Full Text View

Purpose

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.

Condition	Intervention	Phase
Secondary Hyperparathyroidism End Stage Renal Disease	Drug: cinacalcet	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure Nausea and Vomiting

Drug Information available for: Cinacalcet Cinacalcet hydrochloride

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Number of subjects with PTH less than or equal to 300pg/mL [ Time Frame: 21 week dose optimisation phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes [ Time Frame: Dose Optimisation phase 21 weeks ] [ Designated as safety issue: No ]
Safety of cinacalcet [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]

Enrollment:	673
Study Start Date:	September 2004
Study Completion Date:	February 2006
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: During dialysis visit Cinacalcet is given during the dialysis visit	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.
Active Comparator: Post-dialysis meal Cinacalcet is administered with a post-dialysis meal	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117052

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00117052 History of Changes
Other Study ID Numbers:	20040143
Study First Received:	June 30, 2005
Last Updated:	January 20, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Amgen:

Clinical trial
Amgen
Secondary HyperParaThyroidism (SHPT)
Dialysis

End Stage Renal Disease (ESRD)
KDOQI
Cinacalcet

Additional relevant MeSH terms:

Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Parathyroid Diseases

Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013