Intravenous Paricalcitol in Chronic Hemodialysis Patients

Phase 4

• Conditions: Endstage Renal Disease; Secondary Hyperparathyroidism
• Interventions: Drug: Intravenous Paricalcitol

• Registration Number: NCT03023748
• Lead Sponsor: The University of Hong Kong

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Status Verified: 2017-01
• Study First Submitted: 2017-01-07
• Study First Submitted QC: 2017-01-14
• Last Update Submitted: 2017-01-14
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Chronic hemodialysis patients with severe SHPT (defined as iPTH ≥ 800pg/mL) resistant to rocaltrol or alfacalcidol (defined as iPTH not controlled in the range between 2 - 9 times of lab upper limit reference).
• Chronic hemodialysis patients with severe SHPT and at the same time hypercalcemia (defined as serum calcium ≥2.56mmol/L) but still < 2.8mmol/L precluding the use of rocaltrol or alfacalcidol but still feasible to use paricalcitol.

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Exclusion Criteria

• Patients with metastatic malignancy,
• Patients with extremely poor general condition (eg. bedbound) and expected lifespan is below 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravenous paricalcitol solutions	Intravenous Paricalcitol	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.

Primary Outcome Measures

Name	Time	Method
Change in left ventricular mass index	52 weeks and 104 weeks	MRI determined cardiac parameters

Secondary Outcome Measures

Name	Time	Method
Change in Coronary artery calcium score	52 and 104 weeks	Computed tomography determined coronary artery calcium score
Change in Aortic stiffness	52 and 104 weeks	aortic pulse wave velocity
Change in handgrip strength	52 and 104 weeks	nutrition and functional parameters
Change in Serum albumin	52 and 104 weeks	Nutrition parameters
Change in serum Calcium and phosphate	52 and 104 weeks	Biochemical parameters of CKD-MBD
Change in Intact parathyroid hormone	52 and 104 weeks	Biochemical parameters of CKD-MBD
Change in alkaline phosphatase	52 and 104 weeks	biochemical parameters of CKD-MBD

Trial Locations

Locations (1)

Queen Mary Hospital and Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong