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Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

NCT00701805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2011-04-19

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).

Conditions

  • Secondary Hyperparathyroidism
  • Hemodialysis

Interventions

DRUG

Paricalcitol

Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Sponsors & Collaborators

  • Abbott Japan Co.,Ltd

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Moriaki KUBO · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00701805 on ClinicalTrials.gov