NCT00446329

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

First QC Date

March 9, 2007

Last Update Submit

October 28, 2014

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients

    one year period

Interventions

cinacalcetDRUG

Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unstable clinical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, 56403, Greece

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Efstathios Mitsopoulos, MD

    Papageorgiou General Hospital, Thessaloniki, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrologist

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 12, 2007

Study Start

July 1, 2006

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

GR(1)