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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
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
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