Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Phase 4
Terminated
- Conditions
- Secondary Hyperparathyroidism
- Registration Number
- NCT00446329
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients one year period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Papageorgiou General Hospital
🇬🇷Thessaloniki, Greece