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

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00117052

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
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
During dialysis visit: Active Comparator 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.
Post-dialysis meal: Active Comparator 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

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Locations

United States, Ohio
Research Site
Columbus, Ohio, United States
Germany
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Frankfurt (Oder), Germany
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Bovenden, Germany
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Rostock, Germany
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Hürth, Germany
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Kiel, Germany
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Schwabach, Germany
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Heidelberg, Germany
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Eberswalde, Germany
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Duisburg, Germany
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Lübeck, Germany
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Dortmund, Germany
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München, Germany
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Fulda, Germany
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Leipzig, Germany
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Gelsenkirchen, Germany
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Meiningen-Dreißigacker, Germany
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Braunschweig, Germany
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Recklinghausen, Germany
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Wiesbaden, Germany
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Heide, Germany
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Hamburg, Germany
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Bad Mergentheim, Germany
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Wiesloch-Frauenweiler, Germany
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Nürtingen, Germany
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Simmern, Germany
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Großenhain, Germany
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Saalfeld, Germany
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Gießen, Germany
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Berlin, Germany
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Weyhausen, Germany
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Düsseldorf, Germany
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Grimma, Germany
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Nettetal, Germany
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Trier, Germany
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Magdeburg, Germany
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Lünen, Germany
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Wittenberg, Germany
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Meschede, Germany
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Saarbrücken, Germany
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Neuruppin, Germany
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Bochum, Germany
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Limburg, Germany
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Lingen, Germany
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Coburg, Germany
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Bielefeld, Germany
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Lüdenscheid, Germany
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Bad Windsheim, Germany
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Grünstadt, Germany
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Straubing, Germany
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Darmstadt, Germany
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Kassel, Germany
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Bad Kreuznach, Germany
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Westerstede, Germany
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Jena, Germany
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Quedlinburg, Germany
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Dresden, Germany
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Münster, Germany
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Bergisch-Gladbach, Germany
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Kerpen, Germany
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Hof, Germany
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Salzgitter, Germany
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Bamberg, Germany
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Elsenfeld, Germany
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Tangermünde, Germany
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Peine, Germany
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Karlsruhe, Germany
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Emsdetten, Germany
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Neubrandenburg, Germany
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Krefeld, Germany
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Pforzheim, Germany
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Stuttgart, Germany
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Pirmasens, Germany
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Heilbronn, Germany
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Pfarrkirchen, Germany
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Erfurt, Germany
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Freiberg, Germany
Spain
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Lleida, Spain
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A Coruña, Spain
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Madrid, Spain
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Vic, Spain
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Mollet, Spain
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Puerto Real, Spain
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Barcelona, Spain
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Galdakao, Spain
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Alcoy, Spain
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Granada, Spain
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Salamanca, Spain
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Alzira, Spain
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Manresa, Spain
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Cádiz, Spain
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Valencia, Spain
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Huelva, Spain
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Jaén, Spain
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Elche, Spain
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Tarragona, Spain
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Alcorcón, Spain

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:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040143
Study First Received:	June 30, 2005
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00117052 History of Changes
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:

Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Endocrine System Diseases
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms

Pathologic Processes
Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Neoplasm Metastasis
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on November 27, 2009