Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

This study has been terminated.
(due to financial problems)
Information provided by (Responsible Party):
Efstathios Mitsopoulos, Papageorgiou General Hospital Identifier:
First received: March 9, 2007
Last updated: October 28, 2014
Last verified: October 2014

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 Intervention Phase
Secondary Hyperparathyroidism
Drug: cinacalcet
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Papageorgiou General Hospital:

Primary Outcome Measures:
  • Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients [ Time Frame: one year period ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: July 2006
Intervention Details:
    Drug: cinacalcet
    Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.

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

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
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Please refer to this study by its identifier: NCT00446329

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

Responsible Party: Efstathios Mitsopoulos, Nephrologist, Papageorgiou General Hospital Identifier: NCT00446329     History of Changes
Other Study ID Numbers: 109/16-01-2007 
Study First Received: March 9, 2007
Last Updated: October 28, 2014
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Hyperparathyroidism, Secondary
Neoplasm Metastasis
Endocrine System Diseases
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 24, 2016