Sponsor study identifier
interventional
30
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 7, 2017
Actual (reported)January 18, 2017
Actual (reported)December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in left ventricular mass index
MRI determined cardiac parameters
52 weeks and 104 weeks
Change in Coronary artery calcium score
52 and 104 weeks
Change in Aortic stiffness
52 and 104 weeks
Change in handgrip strength
52 and 104 weeks
Change in Serum albumin
52 and 104 weeks
Change in serum Calcium and phosphate
52 and 104 weeks
Intravenous paricalcitol will be administered twice or thrice weekly post-hemodialysis with a dose based on the baseline iPTH level divided by 120. For instance, with a baseline iPTH 1200pg/mL, an induction dose of 10mcg twice or thrice weekly will be given. The maximum weekly dose allowed is 30mcg. Subsequent dose titration may be required depending on the serum PTH level. Intravenous paricalcitol will be continued up to 24 months.
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, 0000, Hong Kong
Angela YM Wang, MD PhD
The University of Hong Kong
First Submitted
January 7, 2017
First Posted
January 18, 2017
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 18, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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