Paricalcitol Injection Phase II Trial

March 26, 2008 updated by: Abbott

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is pharmacokinetic & tolerability.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gunma, Japan
      • Hokkaido, Japan
      • Ibaraki, Japan
      • Kagoshima, Japan
      • Kumamoto, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Saitama, Japan
      • Shizuoka, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: paricalcitol
paricalcitol 0.04 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.08 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.16 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.24 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Experimental: 2
Drug: paricalcitol
paricalcitol 0.04 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.08 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.16 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.24 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Experimental: 3
Drug: paricalcitol
paricalcitol 0.04 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.08 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.16 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.24 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Experimental: 4
Drug: paricalcitol
paricalcitol 0.04 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.08 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.16 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358
Drug: paricalcitol
paricalcitol 0.24 mcg/kg three times a week
Other Names:
  • Zemplar
  • ABT-358

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Hideaki Harada, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J-ZEM-05-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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