Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Phase 4TerminatedNCT00446329

Papageorgiou General Hospital15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism

Interventions

cinacalcetDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Papageorgiou General Hospital

Thessaloniki, Greece

Outcomes

Primary Outcomes

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

Time frame: one year period

Data from ClinicalTrials.gov

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