Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Papageorgiou General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Papageorgiou General Hospital
ClinicalTrials.gov Identifier:
NCT00446329
First received: March 9, 2007
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cinacalcet
    Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Efstathios Mitsopoulos, MD, Papageorgiou General Hospital, Thessaloniki, Greece
ClinicalTrials.gov Identifier: NCT00446329     History of Changes
Other Study ID Numbers: 109/16-01-2007
Study First Received: March 9, 2007
Last Updated: June 5, 2008
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014