A Phase 4 interventional study of Cinacalcet in Hyperparathyroidism and Arterial Stiffness, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-13.
Sponsored by Chinese University of Hong Kong · Phase 4, Interventional, and Treatment
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.
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.
309 studies on the registry are indexed under Hyperparathyroidism; 23 are open to participants now.
This study's enrollment of 44 is below the median of 55 across 205 interventional studies indexed under Hyperparathyroidism.
Browse Hyperparathyroidism studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Oral cinacalcet
Drug: Cinacalcet
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
Also known as: Sensipar
Aortic pulse wave velocity after the cinacalcet treatment
as before
Time frame: change in aortic pulse wave velocity at 52 weeks from baseline
Percent change in the values for parathyroid hormone levels
Blood samples will be stored before and after treatment with cinacalcet for further analysis.
Time frame: within one year of treatment with cinacalcet
Change in calcium levels
as before
Time frame: within one year of treatment with cinacalcet
Aortic pulse wave velocity after the cinacalcet treatment
as stated in the description of Primary Outcome Measure
Time frame: change in aortic pulse wave velocity at 26 weeks from baseline
Change in phosphorus levels
as before
Time frame: within one year of cinacalcet treatment
Change in calcium-phosphorus product
as before
Time frame: within one year of cinacalcet treatment
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cinacalcet
Chinese University of Hong Kong →