NCT00454350

Brief Summary

This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

First QC Date

March 28, 2007

Last Update Submit

May 4, 2015

Conditions

Secondary Hyperparathyroidism

Keywords

Hectorol (doxercalciferol injection)Zemplar (paricalcitol injection)

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic Study

    44 hour interval

Interventions

Hectorol (doxercalciferol injection)DRUG
Zemplar (Paricalcitol injection)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject must be receiving hemodialysis three times per week for a minimum of three months.
  • The subject must be receiving intravenous doxercalciferol or paricalcitol at each dialysis session (three times weekly) for a minimum of 12 weeks prior to Screening.
  • At Screening Visit the subject's laboratory measurements must be within the following ranges: Serum iPTH measurement between 150-800 pg/mL; Corrected calcium measurement ≤ 10.5 mg/dL; Serum phosphorus measurement ≤ 7 mg/dL

You may not qualify if:

  • Any ongoing use of over the counter or prescription vitamin D preparations except doxercalciferol or paricalcitol injection or multivitamins.
  • History of heparin-induced thrombocytopenia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Minneapolis, Minnesota, United States

Location

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

1 alpha-hydroxyergocalciferolparicalcitol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 30, 2007

Study Start

February 1, 2007

Study Completion

July 1, 2007

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

US(1)