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Cinacalcet 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
Papageorgiou General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 9, 2007
Last Updated
October 28, 2014
Sponsor
Papageorgiou General Hospital
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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

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Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

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