Status:
COMPLETED
Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Hyperparathyroidism
Arterial Stiffness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 cardiovascul...
Detailed Description
Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01143987
Start Date
June 1 2010
End Date
February 1 2013
Last Update
November 13 2013
Active Locations (1)
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1
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong, SAR