Trials / Completed
CompletedNCT00646932
Paricalcitol Injection Phase II Trial
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | paricalcitol | paricalcitol 0.04 mcg/kg three times a week |
| DRUG | paricalcitol | paricalcitol 0.08 mcg/kg three times a week |
| DRUG | paricalcitol | paricalcitol 0.16 mcg/kg three times a week |
| DRUG | paricalcitol | paricalcitol 0.24 mcg/kg three times a week |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2007-02-01
- First posted
- 2008-03-31
- Last updated
- 2008-03-31
Locations
10 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00646932. Inclusion in this directory is not an endorsement.