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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117052
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : May 23, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism End Stage Renal Disease Drug: cinacalcet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 673 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism
Study Start Date : September 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with PTH less than or equal to 300pg/mL [ Time Frame: 21 week dose optimisation phase ]

Secondary Outcome Measures :
  1. Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes [ Time Frame: Dose Optimisation phase 21 weeks ]
  2. Safety of cinacalcet [ Time Frame: 21 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117052


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00117052    
Other Study ID Numbers: 20040143
First Posted: July 4, 2005    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013
Keywords provided by Amgen:
Clinical trial
Amgen
Secondary HyperParaThyroidism (SHPT)
Dialysis
 End Stage Renal Disease (ESRD)
KDOQI
Cinacalcet
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Kidney Failure, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists