Intravenous Paricalcitol in Chronic Hemodialysis Patients

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03023748
• Other study ID #: UW11-293
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 7, 2017
• Last updated: January 14, 2017
• Start date: September 2011
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endstage Renal Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital and Tung Wah Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	AbbVie

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular mass index	MRI determined cardiac parameters	52 weeks and 104 weeks
Secondary	Change in Coronary artery calcium score	Computed tomography determined coronary artery calcium score	52 and 104 weeks
Secondary	Change in Aortic stiffness	aortic pulse wave velocity	52 and 104 weeks
Secondary	Change in handgrip strength	nutrition and functional parameters	52 and 104 weeks
Secondary	Change in Serum albumin	Nutrition parameters	52 and 104 weeks
Secondary	Change in serum Calcium and phosphate	Biochemical parameters of CKD-MBD	52 and 104 weeks
Secondary	Change in Intact parathyroid hormone	Biochemical parameters of CKD-MBD	52 and 104 weeks
Secondary	Change in alkaline phosphatase	biochemical parameters of CKD-MBD	52 and 104 weeks