Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Papageorgiou General Hospital

Status and phase: Terminated; Phase 4

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: cinacalcet

Study type: Interventional

Funder types: Other

Identifiers

NCT00446329

109/16-01-2007

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)