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Paricalcitol Injection Phase II Trial

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00646932
Collaborator
(none)
25
Enrollment
10
Locations
4
Arms
2.5
Patients Per Site

Study Details

Study Description

Brief Summary

The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The purpose of this study is pharmacokinetic & tolerability.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
A Phase 2, Open-Label, Multicenter, Multi-Dose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Injection in Chronic Kidney Disease Stage 5 Subjects With Secondary Hyperparathyroidism Undergoing Hemodialysis
Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
Feb 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: paricalcitol
paricalcitol 0.04 mcg/kg three times a week
Other Names:
  • ABT-358
  • Zemplar

    		•
    Experimental: 2

    Drug: paricalcitol
    paricalcitol 0.08 mcg/kg three times a week
    Other Names:
  • ABT-358
  • Zemplar

    		•
    Experimental: 3

    Drug: paricalcitol
    paricalcitol 0.16 mcg/kg three times a week
    Other Names:
  • ABT-358
  • Zemplar

    		•
    Experimental: 4

    Drug: paricalcitol
    paricalcitol 0.24 mcg/kg three times a week
    Other Names:
  • ABT-358
  • Zemplar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics [2 weeks]

    Secondary Outcome Measures

    1. Safety [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure
    Exclusion Criteria:
    • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gunma Japan
    2 Hokkaido Japan
    3 Ibaraki Japan
    4 Kagoshima Japan
    5 Kumamoto Japan
    6 Nagano Japan
    7 Nagasaki Japan
    8 Saitama Japan
    9 Shizuoka Japan
    10 Tokyo Japan

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Hideaki Harada, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00646932
    Other Study ID Numbers:
    • J-ZEM-05-002
    First Posted:
    Mar 31, 2008
    Last Update Posted:
    Mar 31, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Ergocalciferols

    Study Results

    No Results Posted as of Mar 31, 2008