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NCT00646932 Clinical Trial

Paricalcitol Injection Phase II Trial

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00646932
Other study ID # J-ZEM-05-002
Secondary ID
Status Completed
Phase Phase 2
First received March 26, 2008
Last updated March 26, 2008
Start date November 2005

Study information
Verified date March 2008
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Description:

The purpose of this study is pharmacokinetic & tolerability.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• paricalcitol
paricalcitol 0.04 mcg/kg three times a week
• paricalcitol
paricalcitol 0.08 mcg/kg three times a week
• paricalcitol
paricalcitol 0.16 mcg/kg three times a week
• paricalcitol
paricalcitol 0.24 mcg/kg three times a week

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics 2 weeks No
Secondary Safety 2 weeks Yes
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