NCT01143987

Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

Detailed description

Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

Conditions

• Hyperparathyroidism
• Arterial Stiffness

Interventions

Type	Name	Description
DRUG	Cinacalcet	starting with 25 mg daily dose with titration, maximum dose 100 mg daily

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-06-15
• Last updated: 2013-11-13

Locations

1 site across 1 country: Hong Kong