Clinical trial NCT01143987: Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
Official title: Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperparathyroidism
Arterial Stiffness
Keywords: hyperparathyroidism
pulse wave velocity
end-stage renal disease
arterial stiffness
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
* aged 18 or older on peritoneal dialysis for at least three months
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* evidence of cancer, active infection or diseases with limited life expectancy
* diseases known to cause hypercalcaemia
* adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
* participation in another interventional study within last 30 days of randomization
* history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
* patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants

Primary outcomes:
measure: Aortic pulse wave velocity after the cinacalcet treatment
timeFrame: change in aortic pulse wave velocity at 52 weeks from baseline
Secondary outcomes:
measure: Percent change in the values for parathyroid hormone levels
timeFrame: within one year of treatment with cinacalcet
measure: Change in calcium levels
timeFrame: within one year of treatment with cinacalcet
measure: Aortic pulse wave velocity after the cinacalcet treatment
timeFrame: change in aortic pulse wave velocity at 26 weeks from baseline
measure: Change in phosphorus levels
timeFrame: within one year of cinacalcet treatment
measure: Change in calcium-phosphorus product
timeFrame: within one year of cinacalcet treatment
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong, Prince of Wales Hospital
name: Kai Ming Chow, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow KM, Szeto CC, Kwan BC, Cheng PM, Pang WF, Leung CB, Li PK. Effect of cinacalcet treatment on vascular arterial stiffness among peritoneal dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2014 Jun;19(6):339-44. doi: 10.1111/nep.12223.