Paricalcitol Injection Phase II Trial

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: paricalcitol

• Registration Number: NCT00646932
• Lead Sponsor: Abbott

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.

Detailed Description

The purpose of this study is pharmacokinetic \& tolerability.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Last Update Submitted: 2008-03-26
• Study First Posted: 2008-03-31
• Last Update Posted: 2008-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	paricalcitol	-
1	paricalcitol	-
2	paricalcitol	-
4	paricalcitol	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	2 weeks

Secondary Outcome Measures

Name	Time	Method
Safety	2 weeks