Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism
Primary Purpose
Secondary Hyperparathyroidism, End Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
alfacalcidol and calcitriol
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact PTH levels > 300 pg/mL)
Exclusion Criteria:
- (1) age < 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate dialysis [defined as single-pooled Kt/V (sp-Kt/V) <1.2 and <2.0 for thrice a week and twice a week hemodialysis] (4) corrected serum calcium >10.2 mg/dL or serum phosphate >6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland >10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.
Sites / Locations
- Siriraj Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
calcitriol
alfacalcidol
Arm Description
The subjects were randomized to receive calcitriol in a dose-escalating fashion for up to 24 weeks.
Outcomes
Primary Outcome Measures
Reduction of intact parathyroid hormone levels
Secondary Outcome Measures
hypercalcemia and hyperphosphatemia
proportion of the patients who achieved a target PTH, changes in plasma calcium and phosphorus, the proportion of the patients who had hypercalcemia (plasma corrected calcium > 10.8 mg/dl), hyperphosphatemia (plasma phosphorus > 6.0 mg/dl) and calcium-phosphorus products > 55 mg2/dl2 between groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01115543
Brief Title
Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism
Official Title
A Randomized Trial Comparing Pulse Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.
Detailed Description
Secondary hyperparathyroidism has a significant impact on morbidity and mortality in advanced chronic kidney disease (CKD).Both nonselective and selective vitamin D receptor activators (VDRAs) are demonstrated in many studies for their efficacy on suppression of PTH. Most of them are quite expensive and unavailable in many countries. Calcitriol and alfacalcidol are less expensive and worldwidely distributed. There is only one short-term study which directly compares these two drugs. This study demonstrates that calcitriol is superior to alfacalcidol. However, alfacalcidol is a prohormone of calcitriol. It has to be converted by 25-hydroxylase at the liver to generate 1,25-dihydroxyvitamin D3 to act on target cells. Many pharmacokinetics studies demonstrate that alfacalcidol has lower AUC compared to calcitriol if they are administered in the same dose. Therefore, the authors hypothesize that alfacalcidol may be equivalently efficacious as calcitriol if its dose is adjusted according to the pharmacokinetics studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
calcitriol
Arm Type
Active Comparator
Arm Description
The subjects were randomized to receive calcitriol in a dose-escalating fashion for up to 24 weeks.
Arm Title
alfacalcidol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
alfacalcidol and calcitriol
Intervention Description
The initial dose of alfacalcidol was twice that of calcitriol.Both were adjusted to control intact PTH within the ranges of 150-300 pg/ml.
Primary Outcome Measure Information:
Title
Reduction of intact parathyroid hormone levels
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
hypercalcemia and hyperphosphatemia
Description
proportion of the patients who achieved a target PTH, changes in plasma calcium and phosphorus, the proportion of the patients who had hypercalcemia (plasma corrected calcium > 10.8 mg/dl), hyperphosphatemia (plasma phosphorus > 6.0 mg/dl) and calcium-phosphorus products > 55 mg2/dl2 between groups.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact PTH levels > 300 pg/mL)
Exclusion Criteria:
(1) age < 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate dialysis [defined as single-pooled Kt/V (sp-Kt/V) <1.2 and <2.0 for thrice a week and twice a week hemodialysis] (4) corrected serum calcium >10.2 mg/dL or serum phosphate >6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland >10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.
Facility Information:
Facility Name
Siriraj Medical School
City
Bangkok-noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism
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