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
Sponsored by: Abbott
Official(s) and/or principal investigator(s):
Hideaki Harada, Study Director, Affiliation: Abbott
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.
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
The purpose of this study is pharmacokinetic & tolerability.
Minimum age: 20 Years.
Maximum age: 74 Years.
- Subjects with 2┬░HPT who are receiving HD 3 times a week for stable chronic renal
- Subject is considered by investigator, for any reason, to be an unsuitable candidate
for the study
Locations and Contacts
Starting date: November 2005
Last updated: March 26, 2008