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Paricalcitol Injection Phase II Trial

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ClinicalTrials.gov Identifier: NCT00646932
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Abbott

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
Chronic Kidney Disease Drug: paricalcitol Phase 2

Detailed Description:
The purpose of this study is pharmacokinetic & tolerability.

Study Type : Interventional  (Clinical Trial)
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 : November 2005
Actual Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646932


Locations
Japan
Gunma, Japan
Hokkaido, Japan
Ibaraki, Japan
Kagoshima, Japan
Kumamoto, Japan
Nagano, Japan
Nagasaki, Japan
Saitama, Japan
Shizuoka, Japan
Tokyo, Japan
Sponsors and Collaborators
Abbott
Investigators
Study Director: Hideaki Harada Abbott

Responsible Party: Yoshihiko Ueki, Abbott
ClinicalTrials.gov Identifier: NCT00646932     History of Changes
Other Study ID Numbers: J-ZEM-05-002
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents