Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Papageorgiou General Hospital
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

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