NCT00446329TerminatedPhase 4
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Papageorgiou General Hospital2 sites in 1 country15 target enrollmentStarted: July 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- 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
Outcomes
Primary Outcomes
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
Time Frame: one year period
Secondary Outcomes
No secondary outcomes reported
Investigators
Efstathios Mitsopoulos
Nephrologist
Papageorgiou General Hospital
Study Sites (2)
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