Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.
- Conditions
- Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis
- Interventions
- Registration Number
- NCT02895061
- Lead Sponsor
- Phramongkutklao College of Medicine and Hospital
- Brief Summary
Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.
- Detailed Description
ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
- Age ≥ 18 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk
- Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A: Daily Alfacalcidol A: oral daily alfacalcidol treatments total 6 microgram/week B: Pulse Alfacalcidol B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week
- Primary Outcome Measures
Name Time Method Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. 12 week mean PTH reduction between two groups at the end of the study by unpaired-T test.
- Secondary Outcome Measures
Name Time Method