NCT03023748

Intravenous Paricalcitol in Chronic Hemodialysis Patients

Providing Intravenous Paricalcitol Treatment to the Sick and Poor Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism Resistant to Existing Vitamin D Analogs

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endstage Renal Disease
• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	Intravenous Paricalcitol	Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients

Timeline

• Start date: 2011-09-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2017-01-18
• Last updated: 2017-01-18

Locations

1 site across 1 country: Hong Kong