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Paricalcitol Injection Phase II Trial

NCT ID: NCT00646932

Last Updated: 2008-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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

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The purpose of this study is pharmacokinetic \& tolerability.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

paricalcitol

Intervention Type DRUG

paricalcitol 0.04 mcg/kg three times a week

2

Group Type EXPERIMENTAL

paricalcitol

Intervention Type DRUG

paricalcitol 0.08 mcg/kg three times a week

3

Group Type EXPERIMENTAL

paricalcitol

Intervention Type DRUG

paricalcitol 0.16 mcg/kg three times a week

4

Group Type EXPERIMENTAL

paricalcitol

Intervention Type DRUG

paricalcitol 0.24 mcg/kg three times a week

Interventions

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paricalcitol

paricalcitol 0.04 mcg/kg three times a week

Intervention Type DRUG

paricalcitol

paricalcitol 0.08 mcg/kg three times a week

Intervention Type DRUG

paricalcitol

paricalcitol 0.16 mcg/kg three times a week

Intervention Type DRUG

paricalcitol

paricalcitol 0.24 mcg/kg three times a week

Intervention Type DRUG

Other Intervention Names

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ABT-358 Zemplar ABT-358 Zemplar ABT-358 Zemplar ABT-358 Zemplar

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Hideaki Harada

Role: STUDY_DIRECTOR

Abbott

Locations

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Gunma, , Japan

Site Status

Hokkaido, , Japan

Site Status

Ibaraki, , Japan

Site Status

Kagoshima, , Japan

Site Status

Kumamoto, , Japan

Site Status

Nagano, , Japan

Site Status

Nagasaki, , Japan

Site Status

Saitama, , Japan

Site Status

Shizuoka, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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J-ZEM-05-002

Identifier Type: -

Identifier Source: org_study_id