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

Sponsor
Phramongkutklao College of Medicine and Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02895061
Collaborator
(none)
502
Enrollment
2
Arms
12
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
502 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effectiveness Between Daily Versus Pulse Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients: A Randomized Controlled Trial and Multicenter Study
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: A: Daily

A: oral daily alfacalcidol treatments total 6 microgram/week

Drug: Alfacalcidol
Alfacalcidol 1 microgram/capsule
Other Names:
  • oral daily alfacalcidol treatments total 6 microgram/week

    		•
    Experimental: B: Pulse

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

    Drug: Alfacalcidol
    Alfacalcidol 1 microgram/capsule
    Other Names:
  • oral daily alfacalcidol treatments total 6 microgram/week

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Phramongkutklao College of Medicine and Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Phramongkutklao College of Medicine and Hospital
    ClinicalTrials.gov Identifier:
    NCT02895061
    Other Study ID Numbers:
    • PMK-0007
    First Posted:
    Sep 9, 2016
    Last Update Posted:
    May 31, 2017
    Last Verified:
    Jan 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Hyperparathyroidism
    Hyperparathyroidism, Secondary
    Alfacalcidol
    Hydroxycholecalciferols

    Study Results

    No Results Posted as of May 31, 2017