Intravenous Paricalcitol in Chronic Hemodialysis Patients
Primary Purpose
Endstage Renal Disease, Secondary Hyperparathyroidism
Status
Unknown status
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Intravenous Paricalcitol
Sponsored by
About this trial
This is an interventional treatment trial for Endstage Renal Disease focused on measuring activated vitamin D treatment
Eligibility Criteria
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
Sites / Locations
- Queen Mary Hospital and Tung Wah Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intravenous paricalcitol solutions
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in left ventricular mass index
MRI determined cardiac parameters
Secondary Outcome Measures
Change in Coronary artery calcium score
Computed tomography determined coronary artery calcium score
Change in Aortic stiffness
aortic pulse wave velocity
Change in handgrip strength
nutrition and functional parameters
Change in Serum albumin
Nutrition parameters
Change in serum Calcium and phosphate
Biochemical parameters of CKD-MBD
Change in Intact parathyroid hormone
Biochemical parameters of CKD-MBD
Change in alkaline phosphatase
biochemical parameters of CKD-MBD
Full Information
NCT ID
NCT03023748
First Posted
January 7, 2017
Last Updated
January 14, 2017
Sponsor
The University of Hong Kong
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT03023748
Brief Title
Intravenous Paricalcitol in Chronic Hemodialysis Patients
Official Title
Providing Intravenous Paricalcitol Treatment to the Sick and Poor Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism Resistant to Existing Vitamin D Analogs
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
AbbVie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease, Secondary Hyperparathyroidism
Keywords
activated vitamin D treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravenous paricalcitol solutions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous Paricalcitol
Other Intervention Name(s)
Zemplar
Intervention Description
Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients
Primary Outcome Measure Information:
Title
Change in left ventricular mass index
Description
MRI determined cardiac parameters
Time Frame
52 weeks and 104 weeks
Secondary Outcome Measure Information:
Title
Change in Coronary artery calcium score
Description
Computed tomography determined coronary artery calcium score
Time Frame
52 and 104 weeks
Title
Change in Aortic stiffness
Description
aortic pulse wave velocity
Time Frame
52 and 104 weeks
Title
Change in handgrip strength
Description
nutrition and functional parameters
Time Frame
52 and 104 weeks
Title
Change in Serum albumin
Description
Nutrition parameters
Time Frame
52 and 104 weeks
Title
Change in serum Calcium and phosphate
Description
Biochemical parameters of CKD-MBD
Time Frame
52 and 104 weeks
Title
Change in Intact parathyroid hormone
Description
Biochemical parameters of CKD-MBD
Time Frame
52 and 104 weeks
Title
Change in alkaline phosphatase
Description
biochemical parameters of CKD-MBD
Time Frame
52 and 104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela YM Wang, MD PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital and Tung Wah Hospital
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Intravenous Paricalcitol in Chronic Hemodialysis Patients
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