Back to resultsCinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Primary Purpose
Secondary Hyperparathyroidism
Status
Terminated
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
cinacalcet
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility 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
Sites / Locations
- Papageorgiou General Hospital
Outcomes
Primary Outcome Measures
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
Secondary Outcome Measures
Full Information
NCT ID
NCT00446329
First Posted
March 9, 2007
Last Updated
October 28, 2014
Sponsor
Papageorgiou General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00446329
Brief Title
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
due to financial problems
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Papageorgiou General Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cinacalcet
Intervention Description
Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.
Primary Outcome Measure Information:
Title
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
Time Frame
one year period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efstathios Mitsopoulos, MD
Organizational Affiliation
Papageorgiou General Hospital, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papageorgiou General Hospital
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
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