NCT02895061

Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.

Effectiveness Between Daily Versus Pulse Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients: A Randomized Controlled Trial and Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Phramongkutklao College of Medicine and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

Interventions

Type	Name	Description
DRUG	Alfacalcidol	Alfacalcidol 1 microgram/capsule

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-10-01
• Completion: 2016-01-01
• First posted: 2016-09-09
• Last updated: 2017-05-31