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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03023748
Other study ID # UW11-293
Secondary ID
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
Health authority
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

Study Design


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
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