Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis - Full Text View

Sponsored by:	Papageorgiou General Hospital
Information provided by:	Papageorgiou General Hospital
ClinicalTrials.gov Identifier:	NCT00446329

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 IV

MedlinePlus related topics: Dialysis Kidney Failure Minerals

Drug Information available for: Cinacalcet Cinacalcet hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

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:

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

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

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

Study placed in the following topic categories:

Parathyroid Diseases
Hyperparathyroidism, Secondary
Hyperparathyroidism

Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009