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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646932

Enrollment

Registered

2008-03-31

Start date

2005-11-30

Completion date

Unknown

Last updated

2008-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

DRUGparicalcitol

paricalcitol 0.04 mcg/kg three times a week

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics	2 weeks

Secondary

Measure	Time frame
Safety	2 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026