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Paricalcitol Injection Phase II Trial

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00646932
First received: March 26, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 26, 2008
March 26, 2008
November 2005
February 2007   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Safety [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Paricalcitol Injection Phase II Trial
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

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.

The purpose of this study is pharmacokinetic & tolerability.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Chronic Kidney Disease
  • Drug: paricalcitol
    paricalcitol 0.04 mcg/kg three times a week
    Other Names:
    • ABT-358
    • Zemplar
    • paricalcitol
  • Drug: paricalcitol
    paricalcitol 0.08 mcg/kg three times a week
    Other Names:
    • ABT-358
    • Zemplar
    • paricalcitol
  • Drug: paricalcitol
    paricalcitol 0.16 mcg/kg three times a week
    Other Names:
    • ABT-358
    • Zemplar
    • paricalcitol
  • Drug: paricalcitol
    paricalcitol 0.24 mcg/kg three times a week
    Other Names:
    • ABT-358
    • Zemplar
    • paricalcitol
  • Experimental: 1
    Intervention: Drug: paricalcitol
  • Experimental: 2
    Intervention: Drug: paricalcitol
  • Experimental: 3
    Intervention: Drug: paricalcitol
  • Experimental: 4
    Intervention: Drug: paricalcitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
February 2007   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00646932
J-ZEM-05-002
No
Yoshihiko Ueki, Abbott
Abbott
Not Provided
Study Director: Hideaki Harada Abbott
Abbott
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP