This study aims to provide intravenous paritcalcitol treatment for the sick and poor hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D analogs. The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular calcification and stiffness parameters and nutrition status in patients receiving chronic hemodialysis treatment.
This is a 2-year single-arm intervention study of which intravenous paricalcitol will be provided as a second-line treatment to 30 chronic hemodialysis patients with severe SHPT (defined as intact parathyroid hormone \[iPTH\] ≥ 800pg/mL) resistant to existing vitamin D analogs treatment (including rocaltrol and alfacalcidol) or with hypercalcemia (defined as serum calcium ≥2.56mmol/L) precluding the use of existing vitamin D analogs. The study aims to evaluate the control of SHPT, various biochemical parameters of chronic kidney disease-mineral bone disease, left ventricular mass and volumes, vascular calcification and stiffness parameters, handgrip strength and serum albumin with the use of intravenous paricalcitol in patients receiving chronic hemodialysis treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients
Queen Mary Hospital and Tung Wah Hospital
Hong Kong, Hong Kong, Hong Kong
Change in left ventricular mass index
MRI determined cardiac parameters
Time frame: 52 weeks and 104 weeks
Change in Coronary artery calcium score
Computed tomography determined coronary artery calcium score
Time frame: 52 and 104 weeks
Change in Aortic stiffness
aortic pulse wave velocity
Time frame: 52 and 104 weeks
Change in handgrip strength
nutrition and functional parameters
Time frame: 52 and 104 weeks
Change in Serum albumin
Nutrition parameters
Time frame: 52 and 104 weeks
Change in serum Calcium and phosphate
Biochemical parameters of CKD-MBD
Time frame: 52 and 104 weeks
Change in Intact parathyroid hormone
Biochemical parameters of CKD-MBD
Time frame: 52 and 104 weeks
Change in alkaline phosphatase
biochemical parameters of CKD-MBD
Time frame: 52 and 104 weeks
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