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Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

NCT00446329 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-10-29

No results posted yet for this study

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.

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

cinacalcet

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

Sponsors & Collaborators

  • Papageorgiou General Hospital

    lead OTHER

Principal Investigators

  • Efstathios Mitsopoulos, MD · Papageorgiou General Hospital, Thessaloniki, Greece

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446329 on ClinicalTrials.gov