Paricalcitol Injection Phase II Trial

Abbott

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: paricalcitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646932

J-ZEM-05-002

Details and patient eligibility

About

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.

Full description

The purpose of this study is pharmacokinetic & tolerability.

Enrollment: 25 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol

2

Experimental group

Treatment:

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol

3

Experimental group

Treatment:

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol

4

Experimental group

Treatment:

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol

Drug: paricalcitol