Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

October 28, 2014 updated by: Efstathios Mitsopoulos, Papageorgiou General Hospital

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 Overview

Status

Terminated

Conditions

Secondary Hyperparathyroidism

Intervention / Treatment

Drug: cinacalcet

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Greece
- - Thessaloniki, Greece, 56403
    - Papageorgiou General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients Time Frame: one year period	one year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papageorgiou General Hospital

Investigators

Principal Investigator: Efstathios Mitsopoulos, MD, Papageorgiou General Hospital, Thessaloniki, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Registration Dates

First Submitted

March 9, 2007

First Submitted That Met QC Criteria