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Completed

NCT Number: NCT00646932

Paricalcitol Injection Phase II Trial

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gunma, Japan

Loading trial locations.

About this study

The purpose of this study is pharmacokinetic & tolerability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paricalcitol

Drug

paricalcitol 0.04 mcg/kg three times a week

Other names: ABT-358, Zemplar

Primary outcomes

  1. Pharmacokinetics

    Time frame: 2 weeks

Secondary outcomes

  1. Safety

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
First posted
Mar 31, 2008
Registry last updated
Mar 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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