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

Primary Purpose

Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Alfacalcidol

About this trial

This is an interventional treatment trial for Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A: Daily

B: Pulse

Arm Description

A: oral daily alfacalcidol treatments total 6 microgram/week

B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02895061

First Posted

September 4, 2016

Last Updated

May 29, 2017

Sponsor

Phramongkutklao College of Medicine and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02895061

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Phramongkutklao College of Medicine and Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

502 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Daily

Arm Type

Experimental

Arm Description

A: oral daily alfacalcidol treatments total 6 microgram/week

Arm Title

B: Pulse

Arm Type

Experimental

Arm Description

B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week

Intervention Type

Drug

Intervention Name(s)

Alfacalcidol

Other Intervention Name(s)

oral daily alfacalcidol treatments total 6 microgram/week

Intervention Description

Alfacalcidol 1 microgram/capsule

Primary Outcome Measure Information:

Title

Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test.

Description

mean PTH reduction between two groups at the end of the study by unpaired-T test.

Time Frame

12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15807187

Citation

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].

Results Reference

background

PubMed Identifier

16792136

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. doi: 10.5414/cnp65415.

Results Reference

result

PubMed Identifier

9808139

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. doi: 10.1053/ajkd.1998.v32.pm9808139. No abstract available.

Results Reference

result

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

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