We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paricalcitol Injection Phase II Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646932
First Posted: March 31, 2008
Last Update Posted: March 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 2 weeks ]

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
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Yoshihiko Ueki, Abbott
ClinicalTrials.gov Identifier: NCT00646932     History of Changes
Other Study ID Numbers: J-ZEM-05-002
First Submitted: March 26, 2008
First Posted: March 31, 2008
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


To Top