Paricalcitol Injection Phase II Trial
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: paricalcitol (Drug); paricalcitol (Drug); paricalcitol (Drug); paricalcitol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Hideaki Harada, Study Director, Affiliation: Abbott
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.
Clinical Details
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
Study design: Other, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetics
Secondary outcome: Safety
Detailed description:
The purpose of this study is pharmacokinetic & tolerability.
Eligibility
Minimum age: 20 Years.
Maximum age: 74 Years.
Gender(s): Both.
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
Locations and Contacts
Hokkaido, Japan
Ibaraki, Japan
Shizuoka, Japan
Kumamoto, Japan
Gunma, Japan
Kagoshima, Japan
Nagasaki, Japan
Nagano, Japan
Saitama, Japan
Tokyo, Japan
Additional Information
Starting date: November 2005
Last updated: March 26, 2008
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