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

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.

Study Overview

• Status: Unknown
• Conditions: Secondary Hyperparathyroidism; Endstage Renal Disease
• Intervention / Treatment: Drug: Intravenous Paricalcitol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Queen Mary Hospital and Tung Wah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intravenous paricalcitol solutions; 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.

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; Other Names: Zemplar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in left ventricular mass index	MRI determined cardiac parameters	52 weeks and 104 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: AbbVie
• Investigators: Principal Investigator: Angela YM Wang, MD PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: January 7, 2017
• First Submitted That Met QC Criteria: January 14, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 14, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: activated vitamin D treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Parathyroid Diseases; Neoplastic Processes; Renal Insufficiency, Chronic; Hyperparathyroidism; Neoplasm Metastasis; Kidney Failure, Chronic; Hyperparathyroidism, Secondary
• Other Study ID Numbers: UW11-293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO