NCT00646932

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
Last Updated

March 31, 2008

Status Verified

March 1, 2008

Enrollment Period

1.3 years

First QC Date

March 26, 2008

Last Update Submit

March 26, 2008

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    2 weeks

Secondary Outcomes (1)

  • Safety

    2 weeks

Study Arms (4)

1

EXPERIMENTAL
Drug: paricalcitol

2

EXPERIMENTAL
Drug: paricalcitol

3

EXPERIMENTAL
Drug: paricalcitol

4

EXPERIMENTAL
Drug: paricalcitol

Interventions

paricalcitolDRUG

paricalcitol 0.04 mcg/kg three times a week

Also known as: ABT-358, Zemplar
1

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure

You may not qualify if:

  • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Gunma, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hideaki Harada

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

November 1, 2005

Primary Completion

February 1, 2007

Last Updated

March 31, 2008

Record last verified: 2008-03

Locations

JP(10)