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
1 other identifier
interventional
502
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 4, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedMay 31, 2017
January 1, 2015
9 months
September 4, 2016
May 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
A: Daily
EXPERIMENTALA: oral daily alfacalcidol treatments total 6 microgram/week
B: Pulse
EXPERIMENTALB: pulse (trice a week) alfacalcidol treatments total 6 microgram/week
Interventions
Alfacalcidol 1 microgram/capsule
Eligibility Criteria
You may qualify if:
- Age ≥ 18 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk
You may not qualify if:
- Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 15807187BACKGROUNDTarrass 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. doi: 10.5414/cnp65415.
PMID: 16792136RESULTLlach 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. doi: 10.1053/ajkd.1998.v32.pm9808139. No abstract available.
PMID: 9808139RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2016
First Posted
September 9, 2016
Study Start
January 1, 2015
Primary Completion
October 1, 2015
Study Completion
January 1, 2016
Last Updated
May 31, 2017
Record last verified: 2015-01
Data Sharing
- IPD Sharing
- Will not share