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Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

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ClinicalTrials.gov Identifier: NCT00446329
Recruitment Status : Terminated (due to financial problems)
First Posted : March 12, 2007
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Efstathios Mitsopoulos, Papageorgiou General Hospital

Brief Summary:

The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.

The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.


Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: cinacalcet Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: cinacalcet
    Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.


Primary Outcome Measures :
  1. Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients [ Time Frame: one year period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age older than 18 yrs
  • On hemodialysis for at least 3 months (thrice weekly)
  • iPTH >300pg/ml or histological evidence of secondary hyperparathyroidism
  • Calcium > 8.1 mg/dl

Exclusion Criteria:

  • Unstable clinical condition

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): NCT00446329


Locations
Greece
Papageorgiou General Hospital
Thessaloniki, Greece, 56403
Sponsors and Collaborators
Papageorgiou General Hospital
Investigators
Principal Investigator: Efstathios Mitsopoulos, MD Papageorgiou General Hospital, Thessaloniki, Greece

Responsible Party: Efstathios Mitsopoulos, Nephrologist, Papageorgiou General Hospital
ClinicalTrials.gov Identifier: NCT00446329     History of Changes
Other Study ID Numbers: 109/16-01-2007
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs