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

Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895061
• Other study ID #: PMK-0007
• Status: Completed
• Phase: N/A
• First received: September 4, 2016
• Last updated: May 29, 2017
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 y ESRD on HD KT/V = 3.6/wk 2°HPT Stable in P binder for 4 wk

Exclusion Criteria:

• Alfacalcidol allergy Serum Ca = 10.5 mg/dL Serum P = 5.5 mg/dL Pregnancy On phenytoin, phenobarbital

Related Conditions & MeSH terms

• Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis

Intervention

Drug:
• Alfacalcidol
Alfacalcidol 1 microgram/capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

References & Publications (3)

Gu Y, Ding F, Chen N, Mei CL, Qian JQ, Wang XY, Shi W, Hou FF, Li XW, Wang M, Chen YP. Comparisons between oral pulse alfacalcidol therapy and daily therapy in maintenance hemodialysis patients with secondary hyperparathyroidism: a randomized, controlled, and multicenter study. Ren Fail. 2005;27(2):205-12. Erratum in: Ren Fail. 2005;27(6):805. Ding, Feng [added]; Chen, Nan [added]; Mei, Chang-lin [added]; Qian, Jia-qi [added]; Wang, Xiao-yun [added]; Shi, Wei [added]; Hou, Fan-fan [added]; Li, Xue-wang [added]; Wang, Mei [added]; Chen, Yi-pu [added]. — View Citation

Llach F, Yudd M. Pathogenic, clinical, and therapeutic aspects of secondary hyperparathyroidism in chronic renal failure. Am J Kidney Dis. 1998 Oct;32(2 Suppl 2):S3-12. Review. — View Citation

Tarrass F, Yazidi A, Sif H, Zamd M, Benghanem MG, Ramdani B. A randomized trial of intermittent versus continuous oral alfacalcidol treatment of hyperparathyroidism in end-stage renal disease. Clin Nephrol. 2006 Jun;65(6):415-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test.	mean PTH reduction between two groups at the end of the study by unpaired-T test.	12 week