CClinicalTrials.gg
CompletedNCT00454350Updated May 5, 2015

A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis

A Phase 4 interventional study of Hectorol (doxercalciferol injection) and Zemplar (Paricalcitol injection) in Secondary Hyperparathyroidism, sponsored by Genzyme, a Sanofi Company. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-05.

Sponsored by Genzyme, a Sanofi Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Secondary Hyperparathyroidism

Keywords

  • Hectorol (doxercalciferol injection)
  • Zemplar (paricalcitol injection)
03

In context

Hyperparathyroidism

305 studies on the registry are indexed under Hyperparathyroidism; 23 are open to participants now.

This study's planned enrollment of 12 is below the median of 58 across 203 interventional studies indexed under Hyperparathyroidism.

Browse Hyperparathyroidism studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Any ongoing use of over the counter or prescription vitamin D preparations except doxercalciferol or paricalcitol injection or multivitamins.
  • History of heparin-induced thrombocytopenia.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • DrugHectorol (doxercalciferol injection)
  • DrugZemplar (Paricalcitol injection)
06

What researchers measure

Primary outcomes

  1. Pharmacokinetic Study

    Time frame: 44 hour interval

07

Study locations

1 site
  • Minneapolis, Minnesota, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00454350
Lead sponsor
Genzyme, a Sanofi Company
First posted
Mar 30, 2007
Start date
Feb 2007
Completion
Jul 2007
Last update
May 5, 2015

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion