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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
  Purpose

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 Intervention Phase
Chronic Kidney Disease
 Drug: paricalcitol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: November 2005
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: paricalcitol
paricalcitol 0.04 mcg/kg three times a week
Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol
Experimental: 2 Drug: paricalcitol
paricalcitol 0.08 mcg/kg three times a week
Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol
Experimental: 3 Drug: paricalcitol
paricalcitol 0.16 mcg/kg three times a week
Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol
Experimental: 4 Drug: paricalcitol
paricalcitol 0.24 mcg/kg three times a week
Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol

Detailed Description:

The purpose of this study is pharmacokinetic & tolerability.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Yoshihiko Ueki, Abbott
ClinicalTrials.gov Identifier: NCT00646932     History of Changes
Other Study ID Numbers: J-ZEM-05-002
Study First Received: March 26, 2008
Last Updated: March 26, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
 Renal Insufficiency
Ergocalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013