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

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

March 26, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Safety [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Paricalcitol Injection Phase II Trial

Official Title ^ICMJE

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

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.

Detailed Description

The purpose of this study is pharmacokinetic & tolerability.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Chronic Kidney Disease

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Drug: paricalcitol
Experimental: 2
Intervention: Drug: paricalcitol
Experimental: 3
Intervention: Drug: paricalcitol
Experimental: 4
Intervention: Drug: paricalcitol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00646932

Other Study ID Numbers ^ICMJE

J-ZEM-05-002

Has Data Monitoring Committee

Responsible Party

Yoshihiko Ueki, Abbott

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hideaki Harada

Abbott

Information Provided By

Abbott

Verification Date

March 2008

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

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